BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART ADULT SMART PADS CARTRIDGE

    MDR report key: 14475914 · Received May 23, 2022

    Report

    Report Number
    3030677-2022-02678
    Event Type
    Death
    Date Received
    May 23, 2022
    Date of Event
    May 19, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P160029
    Removal / Correction Number
    Z-0881-2022.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BECOME AWARE DATE AND PATIENT CODING TO REFLECT NEW INFORMATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING A PATIENT USE EVENT, THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING A PATIENT USE EVENT, THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675881 HEARTSTART ADULT SMART PADS CARTRIDGE PADS MKJ PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death