BEUDAMED
    FDA Adverse Event Summary report: N

    FR2

    MDR report key: 1942501 · Received December 17, 2010

    Report

    Report Number
    3030677-2010-00356
    Date Received
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED BY DISTRIBUTOR INDICATES THAT AED GAVE LOW BATTERY INDICATION DURING DEPLOYMENT AND POWERED DOWN. NO ADDITIONAL INFO AVAILABLE AT THIS TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3860A-ABD

    Patients

    Seq Age Sex Outcome Treatment
    1