BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3101759 · Received April 26, 2013

    Report

    Report Number
    3030677-2013-00725
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 17, 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). EVAL PENDING. ISSUE IS BEING REPORTED AS POSSIBLE MALFUNCTION PENDING EVAL OF ECG AND/OR FOLLOW-ON INFO REGARDING PT OUTCOME.

    Description of Event or Problem · 1

    CUSTOMER HAS REQUESTED REVIEW OF ECG FROM DEVICE DEPLOYMENT. NO REPORT OF EITHER MALFUNCTION OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182145 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1