BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE MONITOR B650

    MDR report key: 2891424 · Received December 26, 2012

    Report

    Report Number
    9610105-2012-00048
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K102239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE CARESCAPE B650 MONITOR, THE NURSE TILTED THE MONITOR FORWARD TO GET A BETTER VIEW OF THE DISPLAY AND IT FELL AND HIT HER ON THE HEAD. NO SERIOUS INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE HOSPITAL STATED THAT THE TILT SCREW WAS FOUND TO BE MISSING FROM THE TILT BRACKET, WHICH CAUSED THE UNIT TO FALL. THE HOSPITAL STATED THAT 20 OUT OF 21 TILT BRACKETS ARE MISSING THIS TILT SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR B650 MULTI-PARAMETER PATIENT MONITOR MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1