BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2941425 · Received January 31, 2013

    Report

    Report Number
    3030677-2013-00162
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FOR EVAL. PRODUCT EVAL PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR. DATE OF MFR SEPTEMBER 2001.

    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
    42523 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1