BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX- EMS DEFIBRILLATOR

    MDR report key: 3063396 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01123
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    August 15, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED AN ERROR MESSAGE. NO SPECIFIC ERROR WAS NOTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ON (B)(4) 2012, A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE. THE FIELD SERVICE ENGINEER FOUND THAT THE DEVICE COULD NOT ACQUIRE PADS/PADDLES ECG. THE PROBLEM WAS TRACED TO A FAULTY POWER PCA. THIS NEW INFO MAKES THIS A REPORTABLE COMPLAINT. THE POWER PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE. THIS WAS A MALFUNCTION OF THE POWER PCA THAT CAUSED A PADS/PADDLES ECG TEST ERROR. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED AN ERROR MESSAGE. NO SPECIFIC ERROR WAS NOTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127359 HEARTSTART MRX- EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1