BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3021961 · Received March 26, 2013

    Report

    Report Number
    3015876-2013-00232
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN KEYPAD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE REMOVED KEYPAD ASSEMBLY WAS RETURNED TO THE FAILURE ANALYSIS CENTER FOR FURTHER EVALUATION. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE DUE TO DAMAGE TO THE PUSH BUTTON SWITCH FOR THE "CHARGE" KEY. THE SWITCH WAS LOCKED DOWN IN THE SHORTED POSITION, WHICH MEANT IT WAS ALWAYS ACTIVATED AND WOULD NOT ALLOW THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THE CAUSE OF THE DAMAGE TO THE KEY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE WOULD NOT DELIVER A DEFIBRILLATION SHOCK. THE CUSTOMER ATTEMPTED THIS SEVERAL MORE TIMES WITH NO CHANGE IN THE OUTCOME. THE CUSTOMER HAD A BACK UP DEVICE IMMEDIATELY AVAILABLE AND CONTINUED PATIENT CARE. THE CUSTOMER DID NOT REPORT ANY ADVERSE OUTCOME OF THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123752 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR