BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3963035 · Received June 11, 2014

    Report

    Report Number
    3030677-2014-01435
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Report Date
    May 21, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DEVICE VOICE PROMPTS ARE NOT FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345717 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1