BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORERUNNER AED, US ENGLISH, REFURB

    MDR report key: 2597021 · Received May 31, 2012

    Report

    Report Number
    3030677-2012-00562
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Report Date
    May 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST RETURNS)
    Product Code
    MKJ
    PMA / PMN Number
    013425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION BASED ON CUSTOMER DESCRIPTION. NO EVALUATION WILL BE PERFORMED DUE TO AGE OF DEVICE (15 YEARS). CUSTOMER ADVISED TO REMOVE DEVICE FROM SERVICE. #510 K955628.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT AED DID NOT POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORERUNNER AED, US ENGLISH, REFURB MKJ PHILIPS MEDICAL SYSTEMS (HTST RETURNS) E01 46331

    Patients

    Seq Age Sex Outcome Treatment
    1