BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3191492 · Received June 26, 2013

    Report

    Report Number
    3015876-2013-00554
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    November 22, 2012
    Report Date
    June 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE THIRD PARTY SERVICE AGENT RETURNED THE REMOVED PCB ASSEMBLIES TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO-CONTROL EVALUATED THE REMOVED PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U65 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY. THE FAILURE OF U65 ALSO CAUSED THE DEVICE TO NOT RECOGNIZE THE PADDLES LEAD ECG.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP MEDWATCH REPORT INDICATES: THE THIRD PARTY SERVICE AGENT RETURNED THE REMOVED PCB ASSEMBLIES TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO-CONTROL EVALUATED THE REMOVED PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U65 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY. THE FAILURE OF U65 ALSO CAUSED THE DEVICE TO NOT RECOGNIZE THE PADDLES LEAD ECG. THE FOLLOW-UP MEDWATCH REPORT SHOULD INDICATE: THE THIRD PARTY SERVICE AGENT RETURNED THE REMOVED PCB ASSEMBLIES TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO-CONTROL EVALUATED THE REMOVED PCB ASSEMBLIES AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE OF THE DEVICE NOT COMPLETING THE BOOT-UP CYCLE. PHYSIO DID HOWEVER DETERMINE THAT AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U65 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY CAUSED THE LOGGED EVENT CODE IN THE DEVICE AND ALSO CAUSED THE DEVICE TO NOT RECOGNIZE THE PADDLES LEAD ECG. IT IS NOT CONCLUSIVELY KNOWN IF THE PADDLES LEAD ECG FAILURE WAS KNOWN AT THE TIME OF THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE THIRD PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES WERE REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO PHYSIO-CONTROL THAT THE DEVICE HAD ITS SERVICE INDICATOR ILLUMINATED AND HAD LOGGED MULTIPLE EVENT CODES. UPON AN EXAMINATION OF THE DEVICE BY THE THIRD PARTY SERVICE AGENT, IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON AND FUNCTION NORMALLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290030 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1