BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE WARMER

    MDR report key: 8621645 · Received May 17, 2019

    Report

    Report Number
    1121732-2019-00055
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 16, 2019
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K123309
    Removal / Correction Number
    FMI32067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AFTER THREE CALLS (B)(6) 2019. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 20 MARCH 2019. THE GEHC INTERNAL FIELD MODIFICATION NUMBER IS (B)(4). CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO INSPECT THE WARMER BEDSIDE PANEL LATCH AREAS. REPLACEMENT OF BROKEN BEDSIDE PANELS WILL BE PROVIDED BY GEHC. A SET OF WARNING LABELS WILL BE SUPPLIED FOR APPLICATION TO THE BEDSIDE PANELS. THESE LABELS WILL WARN THE USER TO NOT USE THE BEDSIDE PANELS FOR MANEUVERING THE WARMER AND INDICATE THE CORRECT METHOD OF MANEUVERING THE WARMER. AN ADDENDUM TO THE OPERATION AND MAINTENANCE MANUAL WILL ALSO BE PROVIDED EMPHASIZING THE NEED TO CHECK AND ENSURE THAT THE BEDSIDE PANELS AND LATCHES ARE NOT CRACKED, BROKEN, OR DAMAGED BEFORE EVERY PATIENT USE. THE ADDENDUM WILL ALSO CONTAIN INSTRUCTIONS TO INCREASE DETECTABILITY OF BROKEN OR CRACKED BEDSIDE PANELS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED SMALL CRACKS AT THE LATCH POINT OF THE RIGHT SIDE PANEL WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414180 GIRAFFE WARMER WARMER, INFANT RADIANT FMT OHMEDA MEDICAL M1118179

    Patients

    Seq Age Sex Outcome Treatment
    1