BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 8625546 · Received May 20, 2019

    Report

    Report Number
    1220908-2019-01276
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 16, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017644
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE = MKJ. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND MULTI-FUNCTION CABLE WERE RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE AND MULTI-FUNCTION CABLE WERE PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING, ECG FUNCTIONAL STRESS TESTING AND DEFIB FUNCTIONAL STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE DEFIB RECEPTACLE WAS REPLACED AND THE CUSTOMER RECEIVED A REPLACEMENT MULTI-FUNCTION CABLE AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS SHOW THAT THE LOG WAS CLEARED THE DAY AFTER THE REPORTED EVENT AND COULD ADD NO VALUE TO THE INVESTIGATION. THE LOGS WERE REVIEWED FOR THE PERIOD AFTER THE REPORTED EVENT DATE AND NO CRITICAL DEFIB ERRORS WERE FOUND. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) YEAR OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE COMPLAINANT INDICATED THAT THE CLINICIAN POWER CYCLED THE DEVICE AND THE ECG SIGNAL WAS RE-ESTABLISHED AND A "DEFIB ERROR" MESSAGE WAS SEEN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418201 PROPAQ MD DEFIBRILLATOR PROPAQ MD DRT ZOLL MEDICAL CORPORATION PROPAQ MD NA 00847946017644

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR