BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5092253 · Received September 21, 2015

    Report

    Report Number
    3015876-2015-01165
    Event Type
    Death
    Date Received
    September 21, 2015
    Date of Event
    August 9, 2015
    Report Date
    September 21, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO THEN DOWNLOADED THE ELECTRONIC PATIENT RECORD FROM THE EVENT FOR REVIEW. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE ELECTRONIC PATIENT RECORD FROM THE EVENT AND CONFIRMED THAT THE CONNECTION TO THE PATIENT THROUGH THE 3RD PARTY DEFIBRILLATION ELECTRODES WAS INTERMITTENT. MULTIPLE TIMES THROUGHOUT THE EVENT THE PATIENT¿S ECG TRACE WHILE IN PADDLES LEAD ECG WENT TO DASHED LINES (---), INDICATING A LOST CONNECTION TO THE PATIENT. ADDITIONALLY, ON MULTIPLE OCCASIONS BOTH A ¿CHARGE REMOVED¿ AND A ¿LEAD OFF¿ EVENT WAS ANNOTATED BY THE DEVICE. THIS SUGGESTS THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO INADEQUATE PATIENT CONNECTION; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. PHYSIO-CONTROL WAS ADVISED BY THE CUSTOMER THAT THE 3RD PARTY DEFIBRILLATION ELECTRODES USED DURING THE EVENT HAD BEEN DISPOSED OF AND THEREFORE WERE NOT AVAILABLE FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT THAT WAS IN VENTRICULAR FIBRILLATION (V-FIB ). THE PATIENT, A (B)(6) FEMALE, HAD GONE INTO CARDIAC ARREST. A BYSTANDER ADMINISTERED CPR UNTIL THE EMS CREW ARRIVED APPROXIMATELY 4 MINUTES LATER TO CONTINUE PATIENT CARE. THE EMS CREW CONNECTED THE PATIENT TO THEIR DEVICE VIA 3RD PARTY DEFIBRILLATION ELECTRODES (KENDALL MEDITRACE, LOT CODE AND EXPIRATION DATE UNKNOWN); HOWEVER, BASED ON THE ELECTRONIC PATIENT RECORD FROM THE DEVICE, THE CONNECTION TO THE PATIENT THROUGH THE 3RD PARTY DEFIBRILLATION ELECTRODES WAS INTERMITTENT. IN ORDER FOR THE DEVICE TO CHARGE AND SHOCK, THE PATIENT'S HEART RHYTHM MUST BE DETECTABLE IN PADDLES LEAD ECG. A BACKUP DEVICE ARRIVED ON-SCENE AND MEDICAL PERSONNEL CONNECTED THE PATIENT TO THE BACKUP DEVICE VIA A NEW SET OF DEFIBRILLATION ELECTRODES (BRAND UNKNOWN). A SHOCK WAS DELIVERED TO THE PATIENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621688 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death