BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3112491 · Received May 14, 2013

    Report

    Report Number
    3015876-2013-00393
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED LOCK UP FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB AND USER INTERFACE PCB ASSEMBLIES TO OBSERVE PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED USER INTERFACE AND SYSTEM CONTROLLER PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF TWO INTEGRATED CIRCUIT CHIPS, DESIGNATORS U24 AND U25 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY. THE TWO INTEGRATED CIRCUIT CHIPS WOULD INTERMITTENTLY SEND CORRUPTED DATA, WHICH CAUSED THE FAILURE TO BOOT-UP AND ALSO LOGGED MULTIPLE EVENT CODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE POWERS ON WITH WHITE SCREEN AND FAILS TO BOOT UP, LOCK UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212218 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1