BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 4052117 · Received September 2, 2014

    Report

    Report Number
    3015876-2014-01026
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO REPLACED THE MAIN KEYPAD ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED MAIN KEYPAD ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE PACER BUTTON WAS DAMAGED AND PARTIALLY SHORTED. AS A RESULT, WHEN OTHER BUTTONS WERE PRESSED THE PACING FUNCTION WOULD INTERMITTENTLY ACTIVATE. ADDITIONALLY, IT LED TO INTERMITTENT OPERATION OF BOTH THE CHARGE AND SHOCK BUTTONS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT EVENT WHERE THEY WERE MONITORING A PATIENT, WHEN THE DEVICE USER PRESSED THE NIBP BUTTON, THE UNIT WOULD PROMPT THE USER TO "CHECK ELECTRODES." THERE WERE NO ADVERSE EFFECTS REPORTED TO THE PATIENT. UPON EVALUATION OF THE DEVICE, PHYSIO OBSERVED THAT MULTIPLE BUTTONS WERE AFFECTED AND NOT JUST THE NIBP BUTTON. AS A RESULT, DEFIBRILLATION MAY NOT HAVE BEEN POSSIBLE, IF IT WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534770 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1