BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE WARMER

    MDR report key: 14407721 · Received May 16, 2022

    Report

    Report Number
    2112667-2022-01201
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 16, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K122267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE SIDE WALLS WERE REPLACED TO RESOLVE THE ISSUE. NO REPORT OF PATIENT INVOLVEMENT. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THE EAST AND WEST SIDE WALLS WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345646 GIRAFFE WARMER INCUBATOR, NEONATAL FMZ DATEX-OHMEDA, INC. M1118179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown