Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning V60 Ventilators with the Power Management printed circuit board assembly (PCBA) part number 1055906, manufactured by Philips. The affected products are identified as follow:

• Serial Number: 100002908 to 100017733, 100019389 to 100022246, 100023220 to 100108298, 100109211 to 100110991, 100113082, 100113271, 100116388, 100118560, 100118889, 100119580, 100121701, 100126907, 201000040 to 201007766, 201009257, 201010952

According to the manufacturer, a solder connection on the first generation Power Management printed circuit board assembly [(PCBA) P/N 1055906)] of affected devices is subject to solder connection failure. This solder joint connects a component (designated as R31) to the PCBA.

In the most common failure mode of the solder joint, the failure will cause the blower to lose power, spool down, and trigger a visual and audible High Priority "Check Vent" alarm to alert clinicians to switch the patient to alternative ventilation. This failure mode is referred to as an "open failure" . A significantly less common failure mode was identified in which the solder experiences an intermittent connection. The intermittent connection disrupts expected operation and triggers the unit to shutdown unexpectedly. Should this intermittent failure occur, the ventilator will shut down without issuing an alarm.

In the event that the open failure mode occurs, the ventilator will cease to ventilate the patient, but will appropriately alarm to notify clinicians of the need for alternative ventilation. This may lead to moderate patient hypoxemia (reduced blood oxygen level). In rare cases of an intermittent solder joint failure, an unexpected shutdown will occur ceasing ventilation without appropriate alarming and indication. Clinicians will not be alerted to the shut down by the V60 ventilator alarm, which could lead to hypercarbia (excess blood carbon dioxide level) and severe hypoxemia if the loss of ventilation is not otherwise promptly recognized. There has been one report of death that may be related to this problem and three reported events which required switching to alternate means of ventilation.

The manufacturer is advising the affected users for the following actions:

• It is not necessary to remove affected devices from service due to the rarity of these failure modes. Approximately 90% of these failures result in a ventilator alarm, allowing clinicians to arrange for alternative ventilation if the directions in the operator's manual are followed.
• The affected device also has a remote alarm feature that allows the ventilator to be connected to a remote alarm system. If a remote alarm system is installed, the remote alarm will provide a backup alarm even if the ventilator's primary alarm system does not alarm. Directions for connecting a remote alarm system can be found in the Operator's Manual.
• It is important to follow directions in the Operator's Manual and the Field Safety Notice to further reduce any risk associated with this potential failure.
• From the Operator's Manual:
  • Use an external O2 monitor/analyzer and set the alarm thresholds appropriately.
  • Promptly attend to all alarms presented by the ventilator.
  • Ensure that an alternative means of ventilation is available whenever the ventilator is in use.
• Additional directions:
  • If the affected device experiences a shutdown, disconnect the patient and immediately start ventilation with an alternate device. Contact a local customer service to report the failure and to schedule corrective maintenance.

The manufacturer will install a new Power Management PCBA with the newest revision PCBA for the affected users.

For details, please refer to the following link:
https://mhra-gov.filecamp.com/s/YGhdDIZQySvFyj4h/d

Posted on 24 March 2020