BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED CARESTATION

    MDR report key: 12923823 · Received December 3, 2021

    Report

    Report Number
    2112667-2021-02683
    Event Type
    Death
    Date Received
    December 3, 2021
    Date of Event
    November 4, 2021
    Report Date
    April 8, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K152814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION AVAILABLE TO DATE. DATE OF DEATH: NOT PROVIDED. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE ACTUAL ROOT CAUSE IN THIS CASE COULD NOT BE CONCLUSIVELY DETERMINED DUE TO LACK OF DETAILED INFORMATION FROM THE CUSTOMER. THE CUSTOMER DID NOT RESPOND TO GE HEALTHCARE QUESTIONS. HOWEVER, THE DISTRIBUTOR PROVIDED THAT IT APPEARED THE HOSPITAL HAD NOT REMOVED THE CANOPY SEAL OR FAN NECESSARY TO CLEAN, DISINFECT, AND STERILIZE THE UNIT IN ACCORDANCE WITH THE USER MANUAL.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED INFANT DEATH DURING USE OF THE GIRAFFE OMNIBED CARESTATION. THERE WAS NO ALLEGATION OF FAILURE WITH THE GIRAFFE OMNIBED CARESTATION. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824506 GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL FMT DATEX-OHMEDA, INC. 2082844-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death