BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2935505 · Received January 4, 2013

    Report

    Report Number
    1218950-2013-00048
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AT PHILIPS. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE DEVICE PASSED ALL TESTING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS IT COULD NOT BE PRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD A POWER RESET DURING USE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5802 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1