BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2172109 · Received June 15, 2011

    Report

    Report Number
    3030677-2011-00084
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    June 7, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Removal / Correction Number
    Z-0483/88-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SERIAL NUMBER IS ASSOCIATED WITH A FIELD CORRECTION CURRENTLY IN PROCESS (Z-0483/88-2011). AT THIS TIME IT IS UNK WHETHER THAT SELF TEST WARNING IS ASSOCIATED ISSUE ASSOCIATED WITH FIELD CORRECTION.

    Description of Event or Problem · 1

    PRODUCT DISPLAYED SELF TEST WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3860A

    Patients

    Seq Age Sex Outcome Treatment
    1