BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 6147409 · Received December 6, 2016

    Report

    Report Number
    1218950-2016-07659
    Event Type
    Injury
    Date Received
    December 6, 2016
    Report Date
    November 8, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CONDUCTED NUMEROUS TESTS AND WAS UNABLE TO GET THE DEVICE TO FAIL. THE REPORTED PROBLEM WAS NOT CONFIRMED NOR WAS IT REPRODUCED. THE CUSTOMER HAD CHECKED ALL CONNECTIONS THE CUSTOMER HAD USED THE EXISTING PADS ON THE REPLACEMENT DEVICE AND WAS ABLE TO DELIVER A SHOCK. THIS CONFIRMED THAT THE PADS WERE NOT THE PROBLEM. THE DEVICE WAS PUT THROUGH AN OPERATIONAL CHECK BY BOTH THE CUSTOMER AND THE FSE. --THE OPERATIONAL CHECK PASSED. THE FSE ATTEMPTED TO CAUSE THE DEVICE FAILURE BY SHAKING AND MOVING THE CABLES WHILE TESTING. NO FAILURES WERE DETECTED. THE FSE VERIFIED CALIBRATIONS OF THE ETC02 AND NBP, PERFORMED THE JOULES TEST TWICE, AND PERFORMED THE VERIFICATION TESTING PER THE SERVICE MANUAL. NO EVENT SUMMARY OR ECG STRIPS WERE AVAILABLE FOR REVIEW. THE DEVICE PASSED ALL FUNCTIONAL TESTING. THE DEVICE REMAINS AT THE CUSTOMER SITE FOR USE. THE DEVICE IS FULLY OPERATIONAL. NO DEVICE MALFUNCTION WAS OBSERVED, BUT PHILIPS CANNOT RULE OUT THAT A MALFUNCTION OCCURRED AT THAT TIME. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM; NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEFIB PADS FAILED WHILE A PATIENT WAS UNDERGOING CARDIAC ARREST. THE PADS WERE PLACED ON A SECOND DEVICE AND THE THERAPY WAS DELIVERED. IT WAS REPORTED THAT THE DEVICE FAILURE WAS OBSERVED WHILE IN USE ON A PATIENT THAT WAS UNDERGOING CARDIAC ARREST. A SECOND DEVICE WAS USED TO CONTINUE CARE TO THE PATIENT. NO ADVERSE IMPACT WAS REPORTED. THERE IS NO ALLEGATION OR INDICATION THAT THE USE OF THE DEFIBRILLATOR CAUSED OR CONTRIBUTED TO THE NEED TO PROVIDE SHOCK THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799269 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening