BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2241476 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02308
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS HEATLHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE COMPLAINT. PHILIPS HAS NO INFO SUPPORTING THAT THIS UNIT ADVERSELY IMPACTED DIAGNOSIS OR TREATMENT OF A PT WHEN THE PROBLEM WAS OBSERVED. THE PROCESSOR PCA AND POWER MODULE WERE REPLACED DUE TO A LOOSE SCREW RATTLING AROUND INSIDE THE DEVICE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PUT BACK INTO SERVICE. SINCE MULTIPLE ASSEMBLIES WERE REPLACED WE WERE UNABLE TO DETERMINE WHICH PART CAUSED THE FAILURE DUE TO THE LOOSE SCREW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAS A OPS CHECK FAILURE AND GENERAL SYSTEM FAILURE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS HEATLHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1