BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 9100543 · Received September 20, 2019

    Report

    Report Number
    2112667-2019-00440
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    September 11, 2019
    Report Date
    September 20, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE EAST/WEST DOOR KIT WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TWO MISSING DOORS WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893262 GIRAFFE INCUBATOR INCUBATOR, NEONATAL FMZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1