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:
- 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 OR Massimo Technical Services will guide you through a comprehensive screen via phone to determine whether or not your device is affected by this notice
- If your device […]
NOTICE TO HOSPITALS Important Safety Information on Non-Invasive Ventilation Devices
February 7, 2012
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Emergency Medicine, Critical Care, Surgery,
Pediatric Department, Nursing and other involved professional staff and post this NOTICE in
your institution.
Subject: Risk of Non-Invasive Ventilation Devices Being Used as Life-supporting
Ventilators
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 […]
