BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1881567 · Received October 20, 2010

    Report

    Report Number
    3015876-2010-01154
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 21, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE QUIK-COMBO THERAPY CABLE ASSEMBLY WAS REPLACED. IT WAS OBSERVED THAT ONE OF THE BATTERY LATCHES WAS MISSING AND A NEW LATCH WAS INSTALLED. A PERFORMANCE INSPECTION PROCEDURE (PIP), AS OUTLINED IN PRODUCT LITERATURE, WAS PERFORMED ON THE DEVICE. PROPER OPERATION WAS OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY CABLE ASSEMBLY AND OBSERVED THAT WIRES WERE BROKEN AND THE MOLDING AT THE END OF THE CABLE WAS DAMAGED. WHEN THE QUIK-COMBO THERAPY CABLE ASSEMBLY WAS MANIPULATED, ITS RECOGNITION BY THE MOCK-UP DEVICE WAS INTERMITTENT. THE MOST LIKELY CAUSE FOR THE BREAK IN THE WIRES IS EXCESSIVE FORCE IN DISCONNECTING THE QUIK-COMBO THERAPY CABLE ASSEMBLY FROM THE DEVICE. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE DUE TO A BREAK IN THE WIRES OF THE QUIK-COMBO THERAPY CABLE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) CREW WAS DISPATCHED TO THE SCENE OF A CARDIAC ARREST PATIENT AT APPROXIMATELY 23:00 ON (B)(6) 2010. THE PATIENT'S WIFE INDICATED, SHE FOUND HIM UNRESPONSIVE, AFTER SHE HAD SPOKEN WITH HIM 10 MINUTES PRIOR, AND CALLED EMS. THE ALS CREW ARRIVED ON THE SCENE AT APPROXIMATELY 23:01 AND BEGAN THEIR PATIENT ASSESSMENT. THE PATIENT WAS CONNECTED TO THEIR LIFEPAK 12 DEVICE; HOWEVER THE DEVICE DID NOT RECOGNIZE THE PHILIPS DEFIBRILLATION PADS AND PROMPTED "CONNECT ELECTRODES". ANOTHER SET OF DEFIBRILLATION PADS WAS CONNECTED TO THE PATIENT; HOWEVER THE FAILURE REMAINED. THE ALS CREW THEN CONNECTED THE PATIENT TO THE PHILIPS HEARTSTART FR2 AED OF ENGINE CO. 82 AND CONTINUED EVALUATION AND TREATMENT OF THE PATIENT WITH THAT DEVICE. A TOTAL OF SIX (6) DEFIBRILLATION SHOCKS WERE DELIVERED TO THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AT APPROXIMATELY 23:43, ARRIVING AT APPROXIMATELY 23:51. THERE WAS NO REPORT OF COMPROMISE TO PATIENT CARE OR AN ADVERSE EVENT AS A RESULT OF THE REPORTED FAILURE. THE LIFEPAK 12 DEVICE AND ASSOCIATED CABLES WERE REMOVED FROM SERVICE AND FORWARDED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR