BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSENSOR ICP TRANSDUCER

    MDR report key: 1802992 · Received August 11, 2010

    Report

    Report Number
    MW5017100
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 11, 2010
    Manufacturer
    CODMAN
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REPOSITION ICP CODMAN CABLE, CABLE BROKE AT END THAT CONNECTS CODMAN MICROSENSOR ICP TRANSDUCER TO ICU MONITOR. PAC NOTIFIED 2355 ON 7/29. CODMAN WAS TO BE REMOVED ON 7/30 IN AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSENSOR ICP TRANSDUCER GWM CODMAN 480500

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR