BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 ANESTHESIA MONITOR

    MDR report key: 1358031 · Received March 3, 2009

    Report

    Report Number
    9610105-2009-00008
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 9, 2009
    Report Date
    March 3, 2009
    Manufacturer
    GE HEALTHCARE FINLAND QY
    Product Code
    MHX
    PMA / PMN Number
    K051400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S WEIGHT ON PT DATA DEMOGRAPHIC WENT DOWN INCREMENTALLY TO (B) (6) LBS. THE EVENT IS RELATED TO AN ISSUE WHERE THE ANESTHESIA MACHINE OR VENTILATOR DOES NOT RECEIVE THE PT WEIGHT THAT IS CHANGED OR ENTERED IN THE PT MONITOR. THE ANESTHESIA MACHINE OR VENTILATOR SENDS ITS OWN PT WEIGHT TO THE PT MONITOR THAT OVERRIDES THE PT WEIGHT CHANGED OR ENTERED IN THE PT MONITOR, RESULTING IN WRONG PT WEIGHT AND CALCULATED BSA. INCORRECT CALCULATED BSA VALUE MAY FURTHER RESULT IN INCORRECT INDEXED HEMODYNAMIC, OXYGENATION AND VENTILATION ON THE PT MONITOR. WRONG PT WEIGHT MAY AFFECT DRUG CALCULATION VALUES. NO PT INJURY WAS REPORTED. 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 S/5 ANESTHESIA MONITOR MODULAR MONITORS MHX GE HEALTHCARE FINLAND QY F-CU8

    Patients

    Seq Age Sex Outcome Treatment
    1