BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBIRLLATOR/MONITOR

    MDR report key: 1051173 · Received May 22, 2008

    Report

    Report Number
    3015876-2008-00524
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 15, 2008
    Report Date
    April 9, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE PATIENT PARAMETERS PCB ASSEMBLY AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND IT WAS DETERMINED THAT ROOT CAUSE FOR THE REPORTED FAILURE WAS A BLOWN FUSE, F3.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DOES NOT DISPLAY THE ECG SIGNAL, IT ONLY DISPLAYS A DASHED LINE. IT WAS ALSO REPORTED THAT THE DEVICE DATE AND TIME IS OFF AND WILL NOT SET. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBIRLLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA