BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3033457 · Received April 3, 2013

    Report

    Report Number
    3015876-2013-00266
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED EVENT CODES IN THE MEMORY. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL¿S FURTHER DEVICE EVALUATION AT THE FAILURE ANALYSIS CENTER VERIFIED AN INTERMITTENT POWER LOSS FAILURE. THE CAUSE FOR THE MALFUNCTION WAS DETERMINED TO BE A SOLDER SPLASH ACROSS CONTACTS FIVE AND SEVEN OF THE CABLE-MOUNTED PLUG CONNECTOR, DESIGNATOR P16, ON THE ANALOG PCB ASSEMBLY.A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A PATIENT EVENT, IT WAS REPORTED THAT THE DEVICE LOST POWER BEFORE PROVIDING A SHOCK DURING A FULL ARREST. THE DEVICE WAS TURNED BACK ON BUT IT IS UNKNOWN IF THE CUSTOMER ATTEMPTED TO SHOCK THE PATIENT. AN AMBULANCE CREW TOOK OVER THE PATIENT CARE WITHIN 10 SECONDS. THE PATIENT WAS IN ASYSTOLE RHYTHM AND THERE WERE NO SHOCKS DELIVERED TO THE PATIENT. DRUGS WERE ADMINISTERED BUT THE PATIENT RHYTHM REMAINED THE SAME. ONE OF THE RESPONDING AMBULANCE CREW REPORTED THAT IT DID NOT APPEAR THAT THE PATIENT SURVIVED THE EVENT AND THE DEVICE PROBLEM WOULD NOT HAVE AFFECTED THE PATIENT OUTCOME. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136507 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1