BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2292118 · Received October 5, 2011

    Report

    Report Number
    1218950-2011-03042
    Event Type
    Other
    Date Received
    October 5, 2011
    Report Date
    September 8, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT 12 LEAD ECG MONITORING WAS INTERMITTENTLY INTERRUPTED DUE TO LOSS OF "V" LEAD MONITORING. PREVENTION OF DEFIBRILLATOR GENERATED 12 LEAD ANALYSIS COULD CAUSE A DELAY IN PT TREATMENT. NO PT INCIDENT/INJURY WAS REPORTED. THERE WAS NO PRODUCT MALFUNCTION. TESTING SHOWED THAT THE (B)(4) 10 LEAD ECG TRUNK CABLE WAS FUNCTIONING AS DESIGNED. TESTING ALSO SHOWED THAT THE (B)(4) MRX WAS OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 12 LEAD ECG MONITORING WAS INTERMITTENTLY INTERRUPTED DUE TO LOSS OF "V" LEAD MONITORING. PREVENTION OF DEFIBRILLATOR GENERATED 12 LEAD ANALYSIS COULD CAUSE A DELAY IN PT TREATMENT. NO PT INCIDENT/INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1