BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1585131 · Received January 20, 2010

    Report

    Report Number
    1218950-2010-00073
    Event Type
    Other
    Date Received
    January 20, 2010
    Report Date
    December 21, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY LOST PACING WHILE TREATING A PATIENT. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE WAS EVALUATED AT PHILIPS. THE TECHNICIAN COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. WE ARE CONSIDERING THIS A USER ERROR WHERE THE CUSTOMER DID NOT SWITCH TO FIXED MODE PACING WHEN THE ECG SIGNAL WAS INADEQUATE FOR DEMAND MODE PACING. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY LOST PACING WHILE TREATING A PATIENT. NO ADVERSE PATIENT IMPACT 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