BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1842568 · Received September 15, 2010

    Report

    Report Number
    1218950-2010-01597
    Event Type
    Other
    Date Received
    September 15, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REQUESTED INFORMATION REGARDING PACING A PT THROUGH PADS ONLY WHEN AN ECG WAVEFORM VIA LEADS IS NOT AVAILABLE. THE CUSTOMER STATED THAT THERE WAS NO NEGATIVE PT OUTCOME RELATED TO DEVICE BEHAVIOR. INFORMATION WAS PROVIDED TO THE CUSTOMER REGARDING FIXED MODE PACING WHICH DOES NOT REQUIRE THE USE OF ECG LEADS. THE DEVICE WAS FUNCTIONING AS DESIGNED AND INTENDED AND WAS NOT EVALUATED BY PHILIPS. THIS WAS A REQUEST FOR INFORMATION ONLY, AND NO MALFUNCTION. THE CUSTOMER STATED THAT THE INFORMATION PROVIDED BY PHILIPS ADDRESSED THEIR NEEDS.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED INFORMATION REGARDING PACING A PT THROUGH PADS ONLY WHEN AN ECG WAVEFORM VIA LEADS IS NOT AVAILABLE. THE CUSTOMER STATED THAT THERE WAS NO NEGATIVE PT OUTCOME RELATED TO DEVICE BEHAVIOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1