BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING ONSITE

    MDR report key: 2425219 · Received December 29, 2011

    Report

    Report Number
    3030677-2011-00351
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Report Date
    October 28, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL PENDING. INITIAL REPORT IS BEING FILE DAS POTENTIAL MALFUNCTION ON AED WITHIN POPULATION OF Z-1781-2008.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DEVICE ON-OFF BUTTON IS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING ONSITE MKJ PHILIPS MEDICAL SYSTEMS (HTST) M5066A

    Patients

    Seq Age Sex Outcome Treatment
    1