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VEP NEWS

Important COVID-19 Communique From The Ontario Ventilator Equipment Pool (VEP)

COVID-19 COMMUNIQUE – March 19 2020

A message from the Ontario Ventilator Equipment Pool (VEP)

As the COVID-19 situation continues to evolve around the world; the Ontario Ventilator Equipment Pool is monitoring the situation closely and taking precautionary measures to protect our employees, our clients and our community.

The following is a summary of the actions taken by the VEP to date. This communique will be updated, as necessary, to keep you informed. Please continue to check our website for updates.

In response to the COVID-19 issue, we have limited our office to walk-in traffic to those with scheduled appointments only. Clients are asked to call the office at 1-800-633-8977 to schedule an appointment. Active screening is performed prior to scheduling an appointment and again on-site.

We ask that courier and delivery personnel comply with our screening assessment tool when arriving at our facility.

Our plan is to continue to provide service. Our business office remains open weekdays from 09:00am to 5:00pm. Our after-hours telephone troubleshooting service will continue. Respiratory therapists are available 24 hours per day to take calls, troubleshoot equipment issues, and provide education, consultation and follow-up.

Our delivery partners continue to provide service and VEP will continue to ship equipment and supplies as required. We have augmented our delivery service to include additional couriers.

Our infection control practices have been heightened to include an enhanced quarantine period for equipment in addition to rigorous equipment cleaning and disinfection.

In order to protect both patients and healthcare professionals, the VEP has made the difficult decision to suspend in-person home visits effective 2020 March 19 until further notice. Other models of care provision are available to the client including virtual visits using videoconferencing, planned telephone follow-up, educational videos on the VEP website and 24-hour telephone access to our respiratory therapists.

Please reach out to me directly should you have any questions or concerns.

Regina Pizzuti, RRT, Manager
Ontario Ventilator Equipment Pool
1-800-633-8977

Urgent Field Safety Notification Stellar 100/150 Device failure may lead to alarm malfunction

December 27, 2019                                         

Re: Urgent Field Safety Notification
Stellar 100/150 Device failure may lead to alarm malfunction

Dear Ontario Ventilator Equipment Pool (VEP) client, parent, caregiver, substitute decision maker (SDM):

The VEP received notification on December 20th 2019 from ResMed Inc. of an Urgent Field Safety Notification.

Stellar Field Safety Notification 05Dec19

Stellar Avis De Sécurité urgent 05Dec19

You are receiving this letter because our records indicate you have a model ResMed Stellar150 bilevel device with a serial number in the affected serial number range.

Description of the Issue:

ResMed Inc. received a confirmed case of an alarm buzzer not working under the following circumstances: the device has a failed electronic component and, the device is stored without AC power connected for more than 36 hours, leading to full depletion of the battery, and the device powers on automatically when connected to AC power without pressing the power switch. The identified issue is a combination of software and a component failure that may occur in a small number of devices. If a device with this issue is used in the condition described above, the audible alarms may not operate properly.

What to do:

Please read the attached Field Safety Notification and follow the instructions provided by ResMed Inc. ResMed Inc. has issued this notification to help users identify when their device may not be functioning properly and to reinforce the basic instructions and functional tests from the Stellar User Guide. Appendix A, enclosed, is an extract from the Stellar User Guide detailing how to perform a functional test. Make sure your device is functioning properly each time before starting therapy. If you require assistance with performing a functional test please call the VEP during business hours Monday through Friday from 0900 to 1700 at 1-800-633-8977 for phone support by our Respiratory Therapist.

What to do if the device does not pass the functional test:

If your device does not perform as intended after performing the functional test, please provide alternate source of ventilation to the user and notify the VEP at 1-800-633-8977 to arrange for a replacement device.
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If there is a medical emergency please call 911.

ResMed Inc. has notified the Ontario Ventilator Equipment Pool they are developing a solution to correct the performance issue of this device. When this correction becomes available, the VEP will contact you to arrange for service to your device.
Should you have questions regarding this notification, please do not hesitate to contact me directly at 1-800-633-8977 or by email at Regina.Pizzuti@Kingstonhsc.ca

Kind regards,

 

Regina Pizzuti, RRT, BA
Manager, Ontario Ventilator Equipment Pool
Health Canada Recalls & Safety Alerts. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71937r-eng.php#affected-touches

Client FSN letter 2019

Inability to retain user default settings on Rad 8 device after power cycle

Reason for Advisory Notice:

Rad-8 device has been noted to revert back to factory default settings after power cycle. Device functions as intended once user settings are configured or verified after power cycle, there is no impact to performance.

Affected Product:

Rad-8 devices that are used with custom configured settings.

Impact Assessment:

The directions for use for the Rad-8 device indicate that user settings shall be verified at each use. If the end user fails to verify user settings after a power cycle, it is possible that an end user may unintentionally monitor a patient with a Rad-8 device that has reverted back to factory default settings, which may or may not be appropriate for the patient’s clinical condition.

Action to be taken:

If your unit is used with custom configured settings please take one of the following two actions:

  1. Verify functionality of your device using the instructions provided in the URL below. If your device has successfully passed all instructions your device is not affected by this notification and you may resume use.URL:  http://www.masimo.com/training/rad8 ORMassimo Technical Services will guide you through a comprehensive screen via phone to determine whether or not your device is affected by this notice
  2. If your device did not pass the screening, please discontinue use of the device in use case scenarios where custom settings are required. Contact Technical Services to obtain a free software upgrade which will restore user default retention functionality of your device. This upgrade will require sending the Rad-8 device back to Masimo.

Contact Information:

Contact Masimo to obtain a Returned Authorization number or answer any questions or concerns you may have regarding the information above. Region specific contact information is listed below.

Please be assured that Masimo Corporation is committed to consistently providing high quality products and services to our customers. We apologize for any inconvenience this issue may cause you and would like to thank you in advance for your patience and cooperation while we actively work to remedy the issue presented above.

Important Safety Information on Non-Invasive Ventilation Devices

Non-invasive ventilation devices are used to provide non-invasive respiratory support to patients
who experience respiratory insufficiency caused, for instance, by obstructive sleep apnea,
chronic obstructive pulmonary disease and neuromuscular or chest wall disorders. The therapy
has been increasingly used in the emergency and critical care settings for acutely ill patients.
However, Health Canada is concerned about Canadian and international adverse events
associated with these devices being used as life-supporting ventilators. One reported Canadian
case resulted in the patient requiring resuscitation.

Non-invasive ventilation devices can be divided into two groups, continuous positive airway
pressure (CPAP) and variable positive airway pressure (VPAP), also known as Bi-level positive
airway pressure (BiPAP) ventilators. Unlike mechanical ventilators that provide life-sustaining
ventilation, non-invasive ventilators may generally lack a power backup system, alarms, patient
monitoring features and other safety mechanisms that are necessary to protect ventilatordependent
patients against device failure or warn healthcare providers in case of changes in
patients’ health condition.

In order to minimize the risk of patient injury associated with the use of non-invasive ventilation
devices, Health Canada recommends the following:

  1. Non-invasive ventilators are not designed for life-supporting ventilation and should not be used in patients with insufficient respirator drive to tolerate brief interruptions in non-invasive ventilation therapy.  Improper use of these devices may result in patient harm.
  2. Select a compatible mask system recommended by the manufacturers.  Patients who have limited ability to remove the mask should be attended at all times during the therapy to avoid the risk of suffocation caused by prolonged rebreathing of exhaled air due to unexpected device failure.
  3. Closely monitor the patients’ condition when treating with non-invasive ventilation devices by continuing assessing patients’ heart rate, respiratory rate, blood pressure, and oxygen saturation.
  4. Ensure that relevant clinical staff are well trained with knowledge to distinguish these devices from life-supporting ventilators with respect to their different capacities and limitations.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them.  Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments.  Any cases of serious or unexpected adverse incidents in patients using non-invasive ventilation devices should be reported to Health Canada at the following address:

Health Products and Food Branch InspectorateHEALTH CANADA
Address Locator:  2003D
Ottawa, Ontario  K1A 0K9
Tel:  The Inspectorate Hotline  1-800-267-9675

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)
Email:  mhpd_dpsc@hc-sc.gc.ca
Telephone:  613-954-6522
Fax:  613-952-7738