BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3061923 · Received April 16, 2013

    Report

    Report Number
    3015876-2013-00302
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED FAILURE. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    CORRECTION/FOLLOW UP EMDR - THE INITIAL EMDR READS: PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED FAILURE. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. THE INITIAL EMDR SHOULD READ: PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REMOVED SYSTEM PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER VERIFIED THE REPORTED FAILURE. HOWEVER, PHYSIO WAS UNABLE TO DUPLICATE THE REPORTED INTERMITTENT FAILURE AND DETERMINE FURTHER CAUSE FOR THE FAILURE. THE SAME DEVICE FAILURE WAS REPORTED BY PHYSIO-CONTROL ON 3015876-2013-00138 MEDWATCH REPORT. AT THAT POINT IN TIME, PHYSIO WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. HOWEVER, THE CUSTOMER OBSERVED THE SAME FAILURE AND IT WAS REPORTED ON THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO COMPLETE THE BOOT PROCESS. THE DEVICE WOULD NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163715 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1