BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE MONITOR B850

    MDR report key: 2113527 · Received June 1, 2011

    Report

    Report Number
    2124823-2011-00084
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    March 28, 2011
    Report Date
    June 1, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K092027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HIPPA PRIVACY REGULATIONS, THE HOSPITAL WILL NOT PROVIDE PATIENT INFO. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MFR DATE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARESCAPE B850 MONITOR DISPLAYED INCORRECT NON-INVASIVE BLOOD PRESSURE (NIBP) DATA FOR A PT, RESULTING IN INCORRECT TREATMENT. THE NIBP READINGS PRIOR TO ANESTHESIA INDUCTION REPORTEDLY APPEARED TO BE NORMAL. THEN AFTER INDUCTION, THE READINGS STOPPED. TREATMENT WAS GIVEN FOR A CONDITION THAT APPEARED TO BE CONSISTENT WITH PROFOUND HYPOTENSION. IT WAS SUBSEQUENTLY DISCOVERED THAT THE CUFF SETTING WAS SET TO NEONATE MODE. AFTER THE NIBP CUFF SETTING WAS CORRECTED FROM NEONATE TO ADULT MODE, BLOOD PRESSURE WAS NOTED TO BE CRITICALLY HIGH, REQUIRING AGGRESSIVE THERAPY TO RAPIDLY LOWER THE BLOOD PRESSURE. TRANSIENT ST ELEVATION WAS RECORDED, BUT WAS RESOLVED WITH INTERVENTION. THE PT EMERGED FROM ANESTHESIA, COMPLAINED OF NO CHEST PAIN, AND WAS DISCHARGED LATER THE SAME DAY WITHOUT INCIDENT. IT WAS ALLEGED THAT THERE WAS A RANDOM RESET OF THE DEFAULT CUFF SETTINGS TO NEONATE MODE ON ALL MONITORS THAT SAME DAY. THE ANESTHESIOLOGIST REPORTEDLY PLACED LABELS ON THE MONITOR DESCRIBING HOW TO PROPERLY RESET THE MONITORS TO PROPERLY MEASURE BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR B850 MULTI-PARAMETER PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other