BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2792674 · Received October 16, 2012

    Report

    Report Number
    3015876-2012-00770
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLIES AND DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE FAILURE OF AN IC CHIP, DESIGNATOR U61, ON THE PROGRAMMED SYSTEM CONTROLLER PCB ASSEMBLY. THERE WERE NO FAILURES WITH THE REMOVED USER INTERFACE PCB ASSEMBLY AS IT IS AN ANCILLARY PART REMOVED DURING REPAIR.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED LOCK UP FAILURE. PHYSIO REPLACED THE PROGRAMMED SYSTEM 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO BOOT UP PROPERLY AND FROZE AT THE SELF-TEST START UP SCREEN, LOCK UP FAILURE. THE CUSTOMER REBOOTED THE DEVICE AND RESEATED THE POWER SOURCE BUT THE ISSUE PERSISTED. THERE WAS NO KNOWN PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1