BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTREAM FR2

    MDR report key: 2456338 · Received February 10, 2012

    Report

    Report Number
    3030677-2012-00058
    Event Type
    Other
    Date Received
    February 10, 2012
    Report Date
    January 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. RESULTS: IMPEDANCE ISSUES PRESENT DURING DEPLOYMENT. CONCLUSION: LABELING IS PROVIDED TO INSTRUCT THE USER ON OVERCOMING IMPEDANCE ISSUES.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, A SHOCK WAS ABORTED DUE TO IMPEDANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS (HTST) M3840A

    Patients

    Seq Age Sex Outcome Treatment
    1