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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL

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DATEX-OHMEDA, INC. GIRAFFE OMNIBED CARESTATION INCUBATOR, NEONATAL Back to Search Results
Model Number 2082844-001
Device Problem Insufficient Information (3190)
Patient Problem Skull Fracture (2077)
Event Date 05/30/2021
Event Type  Injury  
Manufacturer Narrative
The hospital reported that the nurse who was involved in the incident was located on the right-hand side of the device to provide routine care to (b)(6) day old patient. The nurse moved the patient to the left-hand side of the device, then the left-hand wall panel allegedly fell open and the patient fell out immediately after. The patient received a ct scan and neurological assessment. The ct scan identified a left parietal skull fracture with small hematoma on the scalp. The neurological assessment was normal. Subsequent scans exhibit no changes, and the patient remains stable. An investigation of patient handling and clinical workflow is being performed by the hospital's risk manager at the hospital site. A gehc field engineer visited the site on 04-jun-2021. The device was thoroughly examined using the gehc omnibed service checklist found within the giraffe omnibed service manual which includes, but is not limited to, an inspection of all device walls, wall latches, bed assembly, and overall functionality of the device. The device was found to meet all specifications and no malfunction or breakage was found. The gehc field engineer confirmed that the labeling on the device, associated with field modification instructions (fmi) 32067 (fda res 82485; z-1846-2019, z-1847-2019), was present. The gehc field engineer identified that the hospital had not displayed the fmi 32067 safety poster which had been shipped together with the device on 17-mar-2020. Following the incident, the hospital requested additional safety posters, which were received by the hospital on 10-jun-2021. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported to ge healthcare (gehc) an incident on a giraffe omnibed on (b)(6) with a (b)(6) day old patient. The patient incident occurred right after a shift change and the patient's parents had been the last known individuals to be next to the device prior to the nurse arriving. The hospital staff is not aware to what extent the parents had interacted with the device or the patient. A gehc on-site investigation and examination of the device determined that the device functioned as intended, did not malfunction, and met all specifications. Gehc will submit a follow-up report when the formal investigation has been completed.
 
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Brand NameGIRAFFE OMNIBED CARESTATION
Type of DeviceINCUBATOR, NEONATAL
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3030 ohmeda drive
madison, WI 53718
MDR Report Key11979786
MDR Text Key259454827
Report Number2112667-2021-01495
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2082844-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/10/2021 Patient Sequence Number: 1
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