BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1934124 · Received December 3, 2010

    Report

    Report Number
    3015876-2010-01321
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER AND ORDERING INFO FOR A REPLACEMENT CONNECTOR ASSEMBLY. THE CUSTOMER LATER CONFIRMED THAT THE ASSEMBLY HAS BEEN ORDERED. THE REMOVED ASSEMBLY WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S BIOMED THAT THE DEVICE'S THERAPY CONNECTOR SEEMED LOOSE AND COULD BE CONTRIBUTING TO INTERMITTENT CONNECTIONS. THERE WERE NO REPORTS OF PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA