BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1024183 · Received March 26, 2008

    Report

    Report Number
    3015876-2008-00223
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED CUSTOMER WITH PART NUMBER FOR A REPLACEMENT ADULT PADDLE ADAPTER. THE PADDLE ASSEMBLY WILL NOT BE RETURNED FOR AN EVAL. THE ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPLACE THE DEVICE'S HARD PADDLES. THE REASON FOR REPLACEMENT IS NOT KNOWN, OTHER THAN MAINTENANCE REQUESTED IT. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA