BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3

    MDR report key: 11228775 · Received January 26, 2021

    Report

    Report Number
    3030677-2021-00161
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Report Date
    July 6, 2021
    Manufacturer
    PHILIPS NORTH AMERICA
    Product Code
    MKJ
    UDI-DI
    00884838049994
    PMA / PMN Number
    P160028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE SPEAKERS ARE NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130275 FR3 AED MKJ PHILIPS NORTH AMERICA 861389 00884838049994

    Patients

    Seq Age Sex Outcome Treatment
    1