BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,USB,HE,350-BAS-HE-10

    MDR report key: 7701827 · Received July 19, 2018

    Report

    Report Number
    3004123209-2018-00474
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    July 1, 2018
    Report Date
    July 19, 2018
    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

    THERE WAS NO PATIENT INVOLVED. DEVICE SWITCHES ON AUTOMATICALLY AND LED'S FLASHING UNUSUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546558 PACKAGE,350P,PP03,USB,HE,350-BAS-HE-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1