BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 7938511 · Received October 5, 2018

    Report

    Report Number
    1121732-2018-00008
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    August 17, 2018
    Report Date
    November 9, 2018
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO GE HEALTHCARE (GEHC) THAT, FOLLOWING THE REPORTED EVENT, THE HOSPITAL BIOMED PERFORMED A CHECKOUT OF THE UNIT AND FOUND IT TO FUNCTION WITHIN SPECIFICATION. SUBSEQUENTLY, A GEHC SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND FOUND IT TO FUNCTION WITHIN MANUFACTURERÂS SPECIFICATIONS. GEHCÂS INVESTIGATION DETERMINED THAT ROOT-CAUSE WAS PROBABLE USE ERROR.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALHCARE THAT A BABY WAS PLACED IN THE UNIT. AT SOME POINT, THE BABY WAS FOUND TO BE ON THE FLOOR. THERE WERE REPORTEDLY NO WITNESSES. AS A RESULT OF THE FALL, THE INFANT HAD AN EXTENDED HOSPITAL STAY DUE TO A SUBDURAL HEMATOMA ON THE SIDE OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778479 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMZ OHMEDA MEDICAL 2082844-001

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA Hospitalization