BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 21920202 · Received April 28, 2025

    Report

    Report Number
    3005860720-2025-00015
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    May 1, 2025
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Removal / Correction Number
    Z-0047-2025 & Z-0048-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS HEATER DOOR ISSUE PER 21 CFR 806 ON 22-OCT-2024. THE FDA RECALL NUMBER IS Z-0047-2025 & Z-0048-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING, INSTALLING, AND TIGHTENING THE SCREW THAT SECURES THE HEATER DOOR. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS DISENGAGEMENT OF THE SCREW THAT SECURES THE HEATER DOOR. THEREFORE, THE WAS NO REPORTABLE MALFUNCTION AND THE ISSUE WAS NO ASSOCIATED WITH FDA RECALL NUMBER IS Z-0047-2025 & Z-0048-2025.

    Description of Event or Problem · 0

    THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH THE HEATER DOOR THAT INDICATES IT MAY BE IMPACTED BY THE ISSUE BEING ADDRESSED AS PART OF CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 22-OCT-2024 (Z-0047-2025 & Z-0048-2025). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581064 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown