BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS8401 WITH ONLY CM OF H20 READINGS

    MDR report key: 1883234 · Received October 20, 2010

    Report

    Report Number
    2648988-2010-00083
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE RATCHET SYSTEM ON THE SIDE OF THE PRODUCT THAT RAISES AND LOWERS THE BURETTE WAS WELDED. IT WAS NOT APART FROM THE LEVER TO MOVE. THE PRODUCT WAS CONNECTED TO THE PATIENT FOR A MINUTE AND IT WAS THEN REALIZED THAT THE LEVER COULD NOT BE ADJUSTED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS8401 WITH ONLY CM OF H20 READINGS NA JXG INTEGRA NEUROSCIENCES PR 1103320 OR 1101851

    Patients

    Seq Age Sex Outcome Treatment
    1