BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2821694 · Received November 6, 2012

    Report

    Report Number
    3015876-2012-00827
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A BROKEN AND DAMAGED FILTER, DESIGNATOR FL3 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY. THE FILTER WAS NO LONGER MAKING ANY SOLDER CONTACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SERVICE INDICATOR WAS ILLUMINATED AND THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP PROCESS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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