BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRX+ (W G) DEFIB, JAPANESE, EXCHG

    MDR report key: 17039071 · Received June 1, 2023

    Report

    Report Number
    3030677-2023-02212
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRX DEVICE (B)(6) WAS RETURNED TO PHILIPS FOR ADDITIONAL ANALYSIS. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND THE RESULTS INDICATE THAT THE AED (AUTOMATED EXTERNAL DEFIBRILLATOR) RECEIVED WITH A SHORTED SILICON-CONTROLLED RECTIFIER (SCR), Q3 COMPONENT, CAUSED IT TO EMIT TRIPLE CHIRPS; AFTER REPLACING THE DEFECTIVE COMPONENT, THE DEVICE PASSED ALL TESTS WITHOUT ISSUES, CONFIRMING THAT THE SCR COMPONENT WAS INDEED THE CAUSE OF THE ALLEGED PROBLEM. THE DEVICE INCLUDES REDUNDANT DESIGN FEATURES TO ALERT THE USER IF SERVICE IS NEEDED. THESE FEATURES INCLUDE AN AUDIBLE BEEP AND A FLASHING ¿INFORMATION¿ BUTTON THAT, WHEN PRESSED, WILL CAUSE THE DEVICE TO PROVIDE SPECIFIC VOICE PROMPTS PROVIDING THE USER WITH MORE INFORMATION. BASED ON THE AVAILABLE INFORMATION AND TESTING, THE REPORTED PROBLEM WAS CONFIRMED TO BE A SHORTED SILICON-CONTROLLED RECTIFIER (SCR), Q3 COMPONENT IN THE AED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE, WHICH INVOLVED REPLACING THE SHORTED SILICON-CONTROLLED RECTIFIER (SCR), Q3 COMPONENT IN THE AED, AND THE DEVICE PASSED ALL TESTS WITHOUT ISSUES. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296379 FRX+ (W G) DEFIB, JAPANESE, EXCHG AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown