BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2851443 · Received October 31, 2012

    Report

    Report Number
    1218950-2012-03618
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING SERVICING OF THE DEVICE FOR A REPORTED SYMPTOM OF ARTIFACT THE PHILIPS FIELD SERVICE ENGINEER IDENTIFIED A POWER CYCLING ISSUE. THERE WAS NO REPORTED PT INVOLVEMENT. THE FSE WAS UNABLE TO DUPLICATE THE ARTIFACT SYMPTOM DUE TO THE PRESENCE OF POWER CYCLING. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE SYMPTOMS. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    DURING SERVICING OF THE DEVICE FOR A REPORTED SYMPTOM OF ARTIFACT, THE PHILIPS FIELD SERVICE ENGINEER IDENTIFIED A POWER CYCLING ISSUE. THERE WAS NO REPORTED PT INVOLVEMENT.

    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