BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HWD

    MDR report key: 14085832 · Received April 12, 2022

    Report

    Report Number
    3008642652-2022-03793
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 12, 2022
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005173
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO RECHARGE A BATTERY. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED Q1 CURRENT-CONTROLLING TRANSISTOR ON THE BEDSIDE PCA. THE ROOT CAUSE FOR THE SHORTED Q1 TRANSISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145278 HWD WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION HWD 1000 00855778005173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown