BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2153447 · Received June 21, 2011

    Report

    Report Number
    3030677-2011-00089
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 16, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    Z-0483/0488-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY PENDING DEVICE EVALUATION.

    Description of Event or Problem · 1

    THE DEVICE IS PART OF A RECALL POPULATION AND UPON RECEIPT, IT WAS FOUND TO BE FAILING A SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1