BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLE MOUNT PRESS, MONIT. SYST.

    MDR report key: 408434 · Received July 30, 2002

    Report

    Report Number
    2648988-2002-00015
    Event Type
    Malfunction
    Date Received
    July 30, 2002
    Date of Event
    April 17, 2002
    Report Date
    July 30, 2002
    Manufacturer
    HEYER-SCHULTE NEUROCARE, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THE SEAL ON THE BAG IS NOT OPEN. NO PT CONTACT WAS REPORTED. 07/2002 AN ADD'L REQUEST WAS RECEIVED FROM THE FDA FOR A VOLUNTARY REPORT SUBMITTED FROM THE REPORTING FACILITY ON MAY/2002. THE REPORTING FACILITY INDICATED THAT A NEURO CRITICAL CARE REGISTERED NURSE ATTEMPTED TO FLUSH EXTERIOR VENTRICULAR DRAINAGE SYSTEM PRIOR TO PHYSICIAN PLACING THE VENTRICULOSTOMY IN THE PT. THE NURSE WAS UNABLE TO FLUSH SYSTEM AWAY FROM THE BURITROL. THE SYSTEM OCCLUDED AT PORT NEAREST TO PT. THIS WAS NOTICED PRIOR TO APPLYING TO PT. 07/2002 TELEPHONE CALL PLACED TO USER FACILITY TO CONFIRM THAT THE INFO PROVIDED ON 04/2002 WAS THE SAME INFO AS DESCRIBED TO THE FDA IN THE VOLUNTARY REPORT. THE NURSE CONFIRMED THIS WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLE MOUNT PRESS, MONIT. SYST. * JXG HEYER-SCHULTE NEUROCARE, INC. * 1012298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN