BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM FR2

    MDR report key: 3843028 · Received March 13, 2014

    Report

    Report Number
    3030677-2014-00850
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Report Date
    March 11, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECG AND DEVICE INTERNAL MEMORY WERE REVIEWED. RESULT: ARTIFACT WAS PRESENT DURING ANALYSIS. CONCLUSION: LABELING ALONG WITH VOICE PROMPTS ARE PROVIDED TO INSTRUCT THE USER IN O OVERCOMING ARTIFACT.

    Description of Event or Problem · 1

    DURING DEPLOYMENT, THE USER WAS UNABLE TO OVERCOME AN ARTIFACT DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151815 HEARTSTREAM FR2 MKJ PHILIPS MEDICAL SYSTEMS M3841A

    Patients

    Seq Age Sex Outcome Treatment
    1