BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060114 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00956
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    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

    (B)(4). THE CUSTOMER REPORTED A LEAD FAILURE. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. PER PREVENTATIVE MAINTENANCE AND THE DISCRETION OF THE REPAIR TECHNICIAN THE PROCESSOR PCA WAS REPLACED. THE DEVICE PASSED ALL REQUIRED VERIFICATION TESTING AND HAS BEEN RETURNED TO THE CUSTOMER SITE FOR USE. WE WERE UNABLE TO REPRODUCE THE REPORTED AND THEREFORE UNABLE TO DETERMINE THE CAUSE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAD FAILURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115078 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1