BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060255 · Received March 19, 2013

    Report

    Report Number
    1218950-2013-00930
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE KEEPS GETTING A POWER INTERRUPTED MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND CONFIRMED. THE FIELD SERVICE ENGINEER CHECKED THE PINS ON THE BATTERY PCA BOARD CLOSELY. IT WAS VERIFIED THAT BOTH DOCK A AND B HAVE PROBLEM. THE PROBLEM WAS TRACED TO A FAULTY BATTERY PCA. THE FIELD SERVICE ENGINEER REPLACED THE POWER PCA TO RESOLVE THE PROBLEM. ALL PERFORMANCE ASSURANCE TESTS PASSED AND THE DEVICE WAS PUT BACK INTO SERVICE. THIS IS A MALFUNCTION OF THE POWER PCA THAT CAUSED THE DEVICE TO GET A POWER INTERRUPTED ERROR. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE KEEPS GETTING A POWER INTERRUPTED MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113205 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1