BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART MRX DEFIBRILLATOR

    MDR report key: 9665430 · Received February 4, 2020

    Report

    Report Number
    3007409280-2020-00028
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Report Date
    May 31, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K062233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION IDENTIFIED THAT THE CAPACITOR READING WAS LOW CONFIRMING THE REPORTED EVENT. THE CAPACITOR WAS REPLACED TO INCREASE OUTPUT. THE CIRCUIT BOARDS WERE INSPECTED. THE HOUSING WAS CHECKED FOR DAMAGE. TESTING OF THE DISPLAY, NIBP, ON/OFF POWER, OUTPUT, RECORDER, SPO2, AND TEMP WERE PERFORMED AND PASSED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE AN AGED SHOCK CAPACITOR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE HAD A SHOCK EQUIPMENT MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132355 PHILIPS HEARTSTART MRX DEFIBRILLATOR HEARTSTART MRX MONITOR/DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FQPH6000

    Patients

    Seq Age Sex Outcome Treatment
    1