BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3770558 · Received February 18, 2014

    Report

    Report Number
    3030677-2014-00568
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    January 31, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPORTED AS ISSUE COULD NOT BE CLEARED BY OPERATOR. DUE TO THE AGE OF THE DEVICE, 3 YEARS, THE DEVICE WILL NOT BE REPLACED. CUSTOMER ADVISED TO REMOVE FROM SERVICE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF-DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102611 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1