BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE MONITOR B850

    MDR report key: 2103365 · Received May 17, 2011

    Report

    Report Number
    2124823-2011-00075
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    July 8, 2010
    Report Date
    May 17, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K092027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(4) LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSP. THE ISSUE WAS DISCOVERED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS RELATED TO A KNOWN ISSUE THAT RESULTED IN THE EVENT REPORTED IN MDR 2124823-2011-00052.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT USE, THE CARESCAPE B850 PT MONITOR EMITTED AN UNUSUAL CONSTANT BEEP-BEEP TONE THAT DID NOT AUDIBLY CORRESPOND TO AN EXPECTED ALARM TONE OR OTHER RECOGNIZABLE TONE, AND DID NOT CORRELATE TO ANY VISUAL PT CONDITION. AS LONG AS THIS TONE IS SOUNDING, NO OTHER DISCERNIBLE AUDIBLE ALARMS WILL BE ANNOUNCED. VISUAL ALARMS WERE NOT AFFECTED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT, NOR AN INDICATION THAT INTERVENTION WAS PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    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