BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08

    MDR report key: 8365866 · Received February 25, 2019

    Report

    Report Number
    3004123209-2019-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 25, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    DEVICE RED LED WAS ILLUMINATED AND AUDIO GUIDANCE WHICH TELLS BATTERY LEVEL BECAME LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160082 PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1