The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning HeartStart MRX Defibrillator/Monitor [Model number: M3535A and M3536A], manufactured by Philips Medical Systems.
According to the manufacturer, 71 MRx units may have been built with a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. These devices may fail over time, as repeated shocks continue to be delivered. Should the device fail, the device will no longer be able to deliver shocks in AED mode. The serial numbers of the affected products are as follows:
US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377.
During internal testing, the manufacturer became aware that the affected MRx units contain a component defect . The defective component is a gas discharge tube ("GDT") used to protect other sensitive components within the MRx from the internal high voltages associated with defibrillator shocks. The defective GDT may cause other components to fail after repeated delivery of shocks. This failure may prevent the MRx from automatically detecting critical arrhythmias while in AED Mode, due to excessive artifact on the pads ECG. Shocks delivered in Manual Mode with pads and external paddles are not affected; however, the artifact on the pads ECG may interfere with the user's ability to promptly and accurately identify a shockable rhythm.
According to the manufacturer, if the MRx is being operated in AED Mode and experiences this inability to shock, there will be a delay in delivering any needed shock therapy until either:
In some cases, the user may detect the issue if the MRx fails during a Shift Check, Weekly Shock Test or Operational Check (Op Check), which should be performed periodically, as directed in the Instructions for Use.
For details, please refer to the MHRA's website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-12-to-16-june-2017
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 June 2017