BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1599580 · Received February 3, 2010

    Report

    Report Number
    1218950-2010-00122
    Event Type
    Other
    Date Received
    February 3, 2010
    Report Date
    January 6, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE PADS DURING A PATIENT EVENT. THERE WAS NO NEGATIVE PATIENT IMPACT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE WITH NO TROUBLE FOUND. THE DEVICE WAS FUNCTIONING AS DESIGNED AND INTENDED. A PHILIPS QUALITY INVESTIGATOR REVIEWED THE ELECTRONIC EVENT FILE. THIS WAS A USE ISSUE WHERE THE LEAD SELECT FUNCTION WAS NOT DEPRESSED TO DISPLAY THE AVAILABLE PADS ECG WAVEFORM. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE PADS DURING A PATIENT EVENT. THERE WAS NO NEGATIVE PATIENT IMPACT.

    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