BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060990 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01064
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K033187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE UP/DOWN BUTTONS ON THE DISPLAY WERE BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED TO PHILIPS FOR EVALUATION. THE REPORTED SYMPTOM WAS CONFIRMED. THE SOFTKEY BEZEL WAS MISSING THE UP/DOWN ARROW. THE SOFTKEY BEZEL WAS REPLACED TO RESOLVE THE SYMPTOM. THE PHYSICAL DAMAGED BUTTONS WAS RESOLVED BY REPLACING THE BEZEL ASSEMBLY.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE UP/DOWN BUTTONS ON THE DISPLAY WERE BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124870 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1