BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS1 INFANT/CHILD SMART PADS CARTRIDGE

    MDR report key: 11852410 · Received May 19, 2021

    Report

    Report Number
    3030677-2021-11579
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE INFANT/CHILD PADS HAD THE ADULT PLACEMENT IMAGE DISPLAYED ON THE FOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743138 HS1 INFANT/CHILD SMART PADS CARTRIDGE PADS MKJ PHILIPS NORTH AMERICA LLC Y111220-01

    Patients

    Seq Age Sex Outcome Treatment
    1