BEUDAMED
    FDA Adverse Event Other Summary report: N

    S/5 COMPACT CRITICAL CARE MONITOR

    MDR report key: 2011742 · Received March 3, 2011

    Report

    Report Number
    9610105-2011-00003
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 30, 2011
    Report Date
    March 3, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K021376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. PT ID IS CONFIDENTIAL BY LAW IN FINLAND AND THEREFORE CANNOT BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR PRODUCED INACCURATE ECG READINGS THAT RESULTED IN AN INCORRECT DIAGNOSIS AND TREATMENT OF THE PT. TWO IDENTICAL MODULES, A CARDIAC OUTPUT WITH INVASIVE PRESSURE (COP) AND CARDIAC OUTPUT WITH INVASIVE PRESSURE + SVO2 (COPSV), WERE MISTAKENLY INSERTED IN THE MONITOR FRAME, RESULTING IN ECG INTERFERENCE. MEDICATION WAS ADMINISTERED TO THE PT UNTIL HOSPITAL STAFF REALIZED THE ERROR. THE HOSPITAL STATED THAT THERE IS A WARNING PRINTED ON THE MODULES INSTRUCTING THE USER NOT TO PUT TWO IDENTICAL MODULES IN THE SAME FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 COMPACT CRITICAL CARE MONITOR PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other