BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 13430198 · Received February 2, 2022

    Report

    Report Number
    3005860720-2022-00001
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    December 21, 2021
    Report Date
    April 1, 2022
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION IN THE COMPLAINT AND THE CLINICAL RESEARCH ARTICLE, GE HEALTHCARE CONCLUDED THAT THE CLEANING AND DISINFECTION INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION FOR USE ARE DIFFERENT FROM THE RESEARCH PROTOCOL. THE RESEARCH PROTOCOL DID NOT INCLUDE A DISINFECTION PROCESS FOR ALL NECESSARY PARTS. THERE IS NO CAUSATION BETWEEN THE REPORTED SEPSIS AND THE GIRAFFE OMNIBED.

    Description of Event or Problem · 0

    GE HEALTHCARE (GEHC) BECAME AWARE OF A PUBLICATION THAT ALLEGES A PATIENT DEVELOPED LATE ON SEPSIS DURING AN OBSERVATIONAL STUDY WHILE USING A GIRAFFE OMNIBED. IT IS UNCLEAR IF THERE IS DIRECT CAUSATION BETWEEN THE REPORTED SEPSIS AND THE GIRAFFE OMNIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750023 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other