Philips—HeartStart MRx Monitor/Defibrillators: RFU Indicator May Display an Undocumented Pattern
October 21, 2015 | Risk Management News
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In an October 2015 Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital and posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Philips states that the monitor/defibrillators listed below may stop the automated ready-for-use (RFU) test in an abnormal state when the device is turned off. If this occurs, the RFU indicator window may display a pattern that is not documented in the instructions for use (IFU) or service manual. If this pattern appears and the device is turned on, it will revert the RFU back to an hourglass, indicating that it is fully functional in all monitoring and therapy modes. If this problem occurs, the user may unnecessarily remove the device from service; however, Philips states that the performance of the device is unaffected by this problem. Philips states that there is no clinical risk if the device that has displayed this RFU pattern is turned on and put into service. Philips further states that affected systems will continue to run automated RFU test hourly and report a 0x00C000A4 code in the Status Log summary, as shown in the letter. While an affected system will reliably report this code in the status log, existence of the C000A4 code in the status log does not necessarily mean that the device is experiencing this problem. The manufacturer has not confirmed the...