BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRIKER

    MDR report key: 490317 · Received October 10, 2003

    Report

    Report Number
    MW1029771
    Event Type
    Malfunction
    Date Received
    October 10, 2003
    Date of Event
    August 13, 2003
    Report Date
    October 10, 2003
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAP. CHOLE. PROCEDURE, USING STRYKER HEATED INSUFFLATOR, THE PRESSURE INDICATION WENT UP AND DOWN. PRESSURE ROSE TO 22 MNG WHEN IT WAS SET AT 15 MNG. 2003 THE HERMES 40L INSUFFLATOR WAS REPAIRED BY STRYKER TECHNICIANS AND THEY REPLACED LOW PRESSURE UNIT AND UPGRADED SOFTWARE FOR CENTRAL G. REPLACED DAMAGED CHASIS AND CALIBRATED TO CURRENT SPECS. REPAIRED UNIT RECEIVED BY FACILITY 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRIKER INSUFFLATOR HIF STRYKER ENDOSCOPY HERMES 40 L INSUFFLATOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other