BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 8270167 · Received January 23, 2019

    Report

    Report Number
    1121732-2019-00001
    Event Type
    Death
    Date Received
    January 23, 2019
    Date of Event
    December 25, 2018
    Report Date
    March 22, 2019
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K152814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE FAN FAILURE ALARM CAN GET TRIGGERED WHEN THE FAN IS NOT PUSHED DOWN FAR ENOUGH ONTO THE RUBBER HUB. GIRAFFE OMNIBED CLEANING & CARE GUIDELINES (M1131904 REV A) COVERS THE PROPER REASSEMBLY INSTRUCTIONS OF THE FAN AFTER CLEANING. GE HEALTHCARE ENGINEERING DETERMINED THAT IT IS LIKELY THAT THE IMPROPER SEATING OF FAN OR FAN HUB CONTRIBUTED TO THE INTERMITTENT "¿¿FAN FAILURE ALARM¿?." THE BIOMED STATED THAT THIS PROBLEM IS NOTICED SPORADICALLY WITH OTHER GIRAFFE OMNIBEDS IN THE NICU AS WELL AFTER THE FAN ASSEMBLY WAS DIS-ASSEMBLED AND RE-ASSEMBLED AFTER CLEANING. THEREFORE, THE PROBABLE ROOT CAUSE FOR THE INTERMITTENT FAN FAILURE ALARM COULD BE FAN OR FAN HUB NOT SEATED PROPERLY BY THE HOSPITAL STAFF. THE INFANT'S STATUS WAS FRAGILE AND UNSTABLE FROM TIME OF DELIVERY AND THROUGHOUT THE TIME IN THE NICU. THE INFANT WAS INTUBATED PRIOR TO THE MOVE TO THE NEW BED. AFTER THE MOVE, THE PATIENT CONTINUED TO DE-SATURATE AND REQUIRED A CHEST TUBE. THE UNIT RAISED THE FAN FAILURE ALARM AS DESIGNED. THEREFORE, THE GIRAFFE OMNIBED DID NOT CAUSE OR CONTRIBUTE TO THE INFANT DEMISE.

    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. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE UNIT WENT INTO ALLEGED "FAN FAILURE" ALARM SHORTLY AFTER THE PATIENT, A (B)(6) EARLY NEWBORN, WAS PLACED IN THE OMNIBED IN THE INCUBATOR POSITION. BECAUSE OF THE FAN FAILURE ALARM, THE CUSTOMER HAD TO MOVE THE PATIENT FROM ONE BED TO ANOTHER. THE CUSTOMER STATED THAT ONCE THE PATIENT WAS MOVED, THE INFANT REQUIRED A CHEST TUBE AND THEN VENTILATION ON THE EVENING OF (B)(6). ON (B)(6), THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64298 GIRAFFE OMNIBED NEONATAL INCUBATOR FMZ OHMEDA MEDICAL 6650-0004-901

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death