BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3012542 · Received March 12, 2013

    Report

    Report Number
    3030677-2013-00441
    Event Type
    Death
    Date Received
    March 12, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ECG FROM DEPLOYMENT ASSESSED. ARTIFACT PREVENTED AED FROM ANALYSIS. AED LABELING (INSTRUCTIONS AND VOICE PROMPT(S) PROVIDES INFO REGARDING CAUSES OF ARTIFACT (E.G. CPR, PT HANDLING) AND MEANS OF ADDRESSING ISSUE.

    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
    104308 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death