BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3162459 · Received June 6, 2013

    Report

    Report Number
    3030677-2013-00926
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: REPORTED AS ISSUE COULD NOT BE CLEARED BY OPERATOR. DUE TO AGE OF DEVICE, 11 YEARS, WILL NOT BE REPLACED. CUSTOMER HAS BEEN ADVISED TO REMOVE FROM SERVICE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE AED IS DRAINING BATTERIES TOO QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251910 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1