BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3012567 · Received March 12, 2013

    Report

    Report Number
    3030677-2013-00436
    Event Type
    Death
    Date Received
    March 12, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ECG FROM DEPLOYMENT ASSESSED. REVIEW CONCLUDES THAT CHANGES IN ECG MORPHOLOGY RESULTED IN NO SHOCK DECISIONS. ECG DID NOT MEET ALGORITHM CRITERIA FOR SHOCKABLE RHYTHM.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED PHILIPS FOR REVIEW OF ECG FROM A RESUSCITATION ATTEMPT. PT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104315 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death