BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2082723 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01202
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS CANCELLED BECAUSE CURRENTLY MDR IS BEING USED IN PLACE OF THE SPECIFIC REGION REPORT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED UNEXPECTED PACING BEHAVIOR WHEN USING THE MRX WITH A SIM MAN SIMULATED PT. THIS WAS NOTICED IN SIMULATION TESTING ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1