BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 5084444 · Received September 17, 2015

    Report

    Report Number
    3015876-2015-01140
    Event Type
    Death
    Date Received
    September 17, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 17, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE DEVICE GAVE A "PUSH ANALYZE" PROMPT EVEN THOUGH IT WAS CONFIGURED AS A 2-BUTTON DEVICE (WITHOUT AN ANALYZE BUTTON). THE DEVICE SHOULD AUTOMATICALLY BEGIN AN ECG ANALYSIS AS SOON AS THE DEFIBRILLATION ELECTRODES ARE CONNECTED TO THE TEST LOAD (OR PATIENT). PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE DEVICE'S SHOCK SWITCH WAS STUCK IN THE "DOWN" OR CLOSED POSITION WHICH RESULTED IN THE DEVICE BEHAVING LIKE A 3-BUTTON CONFIGURED DEVICE AND PRODUCING THE "PUSH ANALYZE" VOICE PROMPT. PHYSIO-CONTROL REMOVED THE DEVICE'S UPPER CASE FOR ADDITIONAL EXAMINATION. FOLLOWING REASSEMBLY, PHYSIO OBSERVED PROPER DEVICE OPERATION. THE SHOCK SWITCH FUNCTIONED AS EXPECTED. PHYSIO DID NOT OBSERVE ANY OBVIOUS SIGNS OF DAMAGE TO EITHER THE SWITCH OVERLAY OR THE UPPER CASE ITSELF. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER, A SHERIFF¿S DEPUTY, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR AED DEVICE (¿DEVICE¿) WOULD NOT ANALYZE A PATIENT¿S ECG RHYTHM DURING A RECENT EVENT. AS A RESULT, DEFIBRILLATION WAS NOT POSSIBLE WITH THE DEVICE. THE CUSTOMER REPORTED THAT ONCE THE DEVICE WAS POWERED ON, IT PROMPTED THE DEVICE USERS TO ¿PUSH ANALYZE¿; HOWEVER, THE CUSTOMER¿S DEVICE IS CONFIGURED TO BE AN AUTOMATIC DEVICE WITHOUT AN ANALYZE BUTTON AND, AS A RESULT, IT SHOULD ANALYZE THE PATIENT¿S RHYTHM AUTOMATICALLY AFTER CONNECTION TO THE PATIENT. AFTER APPROXIMATELY 3 MINUTES A BACKUP DEVICE (A LIFEPAK® 1000 AED) ARRIVED ON SCENE AND WAS USED TO CONTINUE PATIENT CARE. ONE SHOCK WAS ADMINISTERED TO THE PATIENT WITH THE BACKUP DEVICE. THE PATIENT, A (B)(6) MALE WEIGHING APPROXIMATELY (B)(6). DID NOT SURVIVE THE EVENT. NO FURTHER DETAILS ABOUT THE PATIENT, OR ADDITIONAL MEDICAL TREATMENT GIVEN TO THE PATIENT, WAS PROVIDED TO PHYSIO-CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615424 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Death