BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE WARMER

    MDR report key: 8128410 · Received December 4, 2018

    Report

    Report Number
    1121732-2018-00011
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 8, 2019
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K101788
    Removal / Correction Number
    FMI32067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    TO ADDRESS THE REPORTED EVENT: 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 DETECT-ABILITY OF BROKEN OR CRACKED BEDSIDE PANELS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR REPORT IS BEING SUBMITTED TO LINK THIS MDR TO RECALL (RES# 82485; Z-1846-2019 & Z-1847-2019), AS FDA HAS CLASSIFIED THIS RECALL AS CLASS I.A.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. MAUDE DATA BASE MDR REPORT SOURCE # (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ANONYMOUS REPORT NUMBER #(B)(4) FROM MAUDE DATABASE STATES, "RN RESPONDED TO MONITOR ALARMING IN PT ROOM. RN FOUND PATIENT LYING ON FLOOR OUT OF GIRAFFE BED, CRYING, WITH BOTTOM SIDE RAIL DOWN. BED WAS FOUND IN THE REVERSE TRENDELENBURG POSITION WHICH IS APPROPRIATE FOR PT. RN HIT EMERGENCY BUTTON AND YELLED FOR HELP. SECOND RN TO BEDSIDE- PICKED PT UP FROM FIRST RN ARMS AND PLACED PT BACK IN BED. PT WAS MOVING ALL FOUR EXTREMITIES APPROPRIATELY AND CRYING SPONTANEOUSLY. PICU TEAM CALLED APN AND MD TO BEDSIDE TO ASSESS PT. PT PLACED BACK ON CARDIAC MONITOR AND SIPAP MACHINE AFTER ASSESSMENT. NEURO CHECK DONE PER MD TO ASSESS PT STATUS. PT WITH APPROPRIATE NEURO ASSESSMENT. Q2 HOUR NEURO CHECKS ORDERED PER PICU TEAM. GIRAFFE BED REMOVED FROM ROOM AND NEW JUNIOR CRIB PLACED IN ROOM." ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT SUFFERED A SKULL FRACTURE FROM THE FALL. THERE WAS NO REPORTED ADDITIONAL MEDICAL INTERVENTION OR EXTENDED HOSPITAL STAY AS A RESULT OF THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969192 GIRAFFE WARMER WARMER, INFANT RADIANT FMT OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DA Other