BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2 WITH AN ECG CABLE

    MDR report key: 2494027 · Received March 14, 2012

    Report

    Report Number
    3030677-2012-00216
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Report Date
    February 22, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    DPS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION PENDING. ISSUE IS BEING REPORTED AS BASED ON AVAILABLE INFORMATION, IT CANNOT BE CONDUCTED THAT RECURRENCE WOULD NOT CAUSE OR CONTRIBUTED TO AN ADVERSE EVENT. ACCESSORY ITEM TO PHILIPS FR2 (510K 003565).

    Description of Event or Problem · 1

    ECG ASSESSMENT MODULE OUT OF BOX FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 WITH AN ECG CABLE DPS PHILIPS MEDICAL SYSTEMS (HTST) M3875 IE111203

    Patients

    Seq Age Sex Outcome Treatment
    1