BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION PRO-PADZ

    MDR report key: 14396102 · Received May 13, 2022

    Report

    Report Number
    MW5109664
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Report Date
    May 12, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PAD PLACED CORRECTLY, HOWEVER A FLAME CAME OUT FROM THE PAD AND IT DID NOT CAUSE PT. SUBSTANTIAL HARM (REDNESS). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310342 ZOLL MEDICAL CORPORATION PRO-PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION 4321B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other