BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 8764692 · Received July 5, 2019

    Report

    Report Number
    1220908-2019-01825
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Report Date
    June 17, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946020217
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE = DRO. THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY RELAY ON THE PROCESSOR/BRIDGE/PACE BOARD. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF-TEST FOR DEFIB AND PACER FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558350 PROPAQ MD DEFIBRILLATOR PROPAQ MD MKJ ZOLL MEDICAL CORPORATION PROPAQ MD NA 00847946020217

    Patients

    Seq Age Sex Outcome Treatment
    1