BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2992244 · Received March 7, 2013

    Report

    Report Number
    3015876-2013-00184
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. A SECOND CLINICAL REVIEW WAS PERFORMED BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER AND THE ELECTRONIC PATIENT RECORD FROM THE DEVICE. IT WAS DETERMINED THAT IT IS LIKELY THAT NEITHER THE DEVICE USE OR THE USE OF THIRD PARTY ELECTRODES CONTRIBUTED TO THE OUTCOME OF THE PATIENT. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AFTER EVALUATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4): A CLINICAL REVIEW OF THE REPORTED EVENT WAS PERFORMED WHERE IT WAS DETERMINED THAT THERE WAS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINED THE IMPACT OF THE DEVICE FAILURE TO THE OUTCOME OF THE PATIENT.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 TO A PHYSIO-CONTROL CUSTOMER SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE DID NOT FUNCTION WHEN USED ON A PATIENT WITH CARDIAC ARREST. THE HOSPITAL CREW APPLIED THE THIRD-PARTY DEFIBRILLATION ELECTRODES (SKINTACT) TO THE PATIENT AND STARTED TO ANALYZE BUT THE DEVICE DID NOT SHOW A READING. THE CREW GOT A BACK-UP DEVICE FROM A NEARBY WARD. THE DELAY IN GETTING THE ANALYSIS WAS APPROXIMATELY 1-2 MINUTES. THE PATIENT RECOVERED FOR A WHILE BUT PASSED AWAY APPROXIMATELY 1 HOUR AFTER THE TREATMENT. AFTER THE EVENT THE DEVICE WAS CHECKED BY THE HOSPITAL STAFF AND IT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97470 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR DEFIBRILLATION ELECTRODES FROM SKINTACT