BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRX (W B) DEFIB, THAI, EXCHG

    MDR report key: 13772673 · Received March 15, 2022

    Report

    Report Number
    3030677-2022-01564
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838080768
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    510K CORRECTED TO P180028.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37708 FRX (W B) DEFIB, THAI, EXCHG AED MKJ PHILIPS NORTH AMERICA LLC 861304 00884838080768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown