BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSARESCAPE MONITOR B850

    MDR report key: 4384671 · Received January 2, 2015

    Report

    Report Number
    9610105-2015-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    November 28, 2014
    Report Date
    December 3, 2014
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K092027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANALYSIS OF THE B850 LOG FILES AND PATIENT CASE FILES COLLECTED BY ICENTRAL DURING THE TIME PERIOD OF THE REPORTED MISSING SPO2 ALARM SHOWED THAT ALL OCCURRENCES OF SPO2 GOING BELOW THE SET LIMIT OF 90% HAD CORRECTLY PRODUCED AN ALARM. NO DEFECT WAS DETECTED, THE B850 WORKED AS SPECIFIED. DATE OF EVENT IS: (B)(6) 2014. EVENT DESCRIPTION CLARIFIED: IT WAS REPORTED THAT THE MONITOR DID NOT ALARM FOR A DECREASED SPO2. THERE WAS NO REPORTED PATIENT CONSEQUENCE. BRAND NAME IS: CARESCAPE MONITOR B850. D2B PROCODE IS: MHX. (B)(4). DEVICE MANUFACTURE DATE IS: 03/01/2011.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ICENTRAL DID NOT ALARM FOR VITAL PARAMETERS. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DID NOT ALARM FOR A DECREASED SPO2. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473 CSARESCAPE MONITOR B850 PHYSIOLOGICAL MONITORS SYSTEM MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1