BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3824073 · Received May 21, 2014

    Report

    Report Number
    3015876-2014-00581
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND OBSERVED THAT A WIRE HARNESS CONNECTOR, DESIGNATOR P22 WAS NOT FULLY CONNECTED TO ITS CORRESPONDING CONNECTOR ON THE THERAPY PCB ASSEMBLY, DESIGNATOR J22. THIS WIRE HARNESS CONNECTOR, DESIGNATOR P22, PROVIDES VOLTAGE TO THE DEFIBRILLATION TRANSFER RELAY COIL. WITHOUT THIS CONNECTION COMPLETED, THE DEVICE DID NOT HAVE THE ABILITY TO DELIVER DEFIBRILLATION ENERGY.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE DEVICE AND OBSERVED VIA X-RAY THAT THE RELAY COIL WAS DISCONNECTED FROM THE THERAPY PCB ASSEMBLY.PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY TO THEIR PATIENT. THE CUSTOMER STATED THAT ONCE THIS FAILURE OCCURRED, THEY DEPLOYED THEIR BACK UP DEVICE WITHIN A MINUTE OF THE FAILURE. THE BACKUP DEVICE DID DELIVER DEFIBRILLATION ENERGY TO THE PATIENT. THE OUTCOME AND DETAILS OF THE PATIENT WERE NOT REPORTED. IT IS UNKNOWN IF THE PATIENT SUFFERED ANY ADVERSE EFFECTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED FROM THE CUSTOMER REGARDING THE PATIENT EVENT. AFTER THE BACK-UP DEVICE CONTINUED CARE AND DELIVERED ONE SHOCK, THE PATIENT WAS TRANSPORTED TO THE LOCAL HOSPITAL. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303096 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death