BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAM

    MDR report key: 1051473 · Received May 21, 2008

    Report

    Report Number
    2124823-2008-00052
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 21, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NIBP "NO DETERMINATION" OCCURRED IN THE OPERATING THEATER DURING A CASE WITH SOLAR AND TRAM MODULE BEING USED IN CONJUNCTION WITH AVANCE ANESTHESIA MACHINE. THE USER WAS ALLEGEDLY UNABLE TO MEASURE NON-INVASIVE BLOOD PRESSURE REQUIRING PROLONGED ANESTHESIA AND SURGERY WITH DISATTACHMENT AND REATTACHMENT OF ROBOT REQUIRED. THE HOSPITAL HAS NOT PROVIDED INFO THAT A PT INJURY DID OCCUR. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAM PHYSIOLOGIC PT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR