BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    MDR report key: 2855612 · Received November 30, 2012

    Report

    Report Number
    3006697299-2012-00050
    Event Type
    Death
    Date Received
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    "THE CENTER NOTIFIED THE DISTRIBUTOR OF A PROBLEM ON (B)(6) 2012, REGARDING A CUSA EXCEL WHICH WAS DESCRIBED AS FOLLOWS; "ACCORDING TO THE CONTRACT (BETWEEN THE DISTRIBUTOR AND THE HOSP), THE DISTRIBUTOR MUST COMPLETE THE REPAIR WITHIN 10 DAYS. THE DISTRIBUTOR HAS NOT YET REACHED THE DEADLINE OF THE SERVICE PERIOD, HOWEVER THE LOSS OF A PT DUE TO THE DEVICE WILL CREATE SOME PROBLEMS AND THE DISTRIBUTOR EXPECT THE HOSP TO TAKE THE ISSUE TO (B)(6). THE DISTRIBUTOR INFORMED US THAT HE WAS NOT ABLE TO PERFORM THE SERVICE FOR THE DEVICE BECAUSE OF THE LACK OF SOME SPARE PARTS." THE UNIT WAS NOT IN CONTACT WITH THE PT. THE UNIT IS DEFECTIVE AND THEREFORE COULD NOT BE USED FOR A PT WHO REQUIRED URGENT ORGAN TRANSPLANT. THE UNIT AT THIS HOSP REQUIRES REPLACEMENT OF CUSA EXCEL ULTRASONIC BOARD ASSEMBLY ((B)(4))."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONSOLE WITH FOOTSWITCH EACH1 NONE LBK INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death