BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060942 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01062
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE PROBLEM WAS LOCALIZED TO THE AC POWER MODULE. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE PROBLEM WAS LOCALIZED TO THE AC POWER MODULE. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE SYMPTOM. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE POWER SYMPTOM WAS RESOLVED WITH AC POWER MODULE REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS "FREEZING UP." THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123051 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1