BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3903025 · Received June 30, 2014

    Report

    Report Number
    3015876-2014-00740
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 2, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO THEN REPLACED BOTH THE SYSTEM CONTROLLER (SC) PCB AND THE USER INTERFACE (UI) PCB ASSEMBLIES TO RESOLVE THE REPORTED ISSUE. AFTER COMPLETING OTHER UNRELATED REPAIRS AND OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.PHYSIO FURTHER EVALUATED THE REMOVED SC PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61.THE REMOVED UI PCB ASSEMBLY WAS AN ANCILLARY PART AND THERE WAS NO FAILURE OF THIS ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT AFTER ATTEMPTING TO REPAIR THEIR DEVICE FOR A NON-CRITICAL ISSUE IT WOULD NO LONGER COMPLETE THE BOOT-UP CYCLE. THE BIOMED ADVISED THAT THERE WEREN'T ANY BOOT-UP ISSUES PRIOR TO HIS REPAIR, SO AT THE TIME, IT WAS REASONABLE TO CONCLUDE THAT THE REPORTED ISSUE WAS THE RESULT OF THE REPAIR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO DETERMINED THAT THE REPORTED BOOT-UP ISSUE WAS THE RESULT OF A DEVICE MALFUNCTION AND NOT THE RESULT OF THE BIOMEDICAL ENGINEERS ATTEMPT TO REPAIR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380720 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1