BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEWLETT PACKARD NBP MODULE FOR CMS SYSTEM

    MDR report key: 35408 · Received July 3, 1996

    Report

    Report Number
    35408
    Event Type
    Other
    Date Received
    July 3, 1996
    Date of Event
    February 5, 1996
    Report Date
    May 9, 1996
    Manufacturer
    HEWLETT PACKARD
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 49-YR-OLD FEMALE UNDERWENT A TOTAL KNEE REPLACEMENT ON 2/5/96 UNDER REGIONAL ANESTHESIA. THE PT'S BLOOD PRESSURE WAS BEING MONITORED BY CO'S MODULE DURING THE PROCEDURE. CUFF INFLATIONS WERE INTERMITTENT. THE PT WAS AWAKE DURING THE ENTIRE TWO HR PROCEDURE. POST OPERATIVELY, THE PT COMPLAINED OF NUMBNESS IN HER RIGHT ARM. THE COMPLAINT IS FIRST DOCUMENTED 48 HRS POST-OP. THE NEUROPATHY IS NOT KNOWN TO HAVE BEEN CAUSED BY COMPRESSION FROM THE CUFF, HOWEVER, NO OTHER ETIOLOGY HAS BEEN IDENTIFIED. NO PROBLEMS WITH THE MACHINE WERE NOTED DURING THE PROCEDURE. AN ELECTROMYOGRAPHY STUDY WAS PERFORMED ON 4/26/96 INDICATED THAT THE PT HAD AN ULNAR NEUROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD NBP MODULE FOR CMS SYSTEM NBP MODULE FOR CMS SYSTEM DXN HEWLETT PACKARD 1008B *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other