BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3883437 · Received June 19, 2014

    Report

    Report Number
    3015876-2014-00675
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY IN THE FAILURE ANALYSIS CENTER. PHYSIO OBSERVED THAT THE POWER SUPPLY ASSEMBLY ONLY WAS HAVING A FAILURE WITH PROVIDING AC POWER AND DC POWER WAS STILL FUNCTIONAL WITH A CHARGED BATTERY.THE CAUSE OF THE OBSERVED AC POWER WAS DETERMINED TO BE TWO SHORTED TRANSISTORS, DESIGNATORS Q1 AND Q2 AND ALSO AN OPEN FUSE, DESIGNATOR F1.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NO LONGER POWER ON WITH AC POWER. AFTER AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361052 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1