BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3012985 · Received March 1, 2013

    Report

    Report Number
    3030677-2013-00371
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89996 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3860A 48549P

    Patients

    Seq Age Sex Outcome Treatment
    1