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

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.

Manufacturer Narrative

Block h10: ge healthcare (gehc) product engineering performed an investigation of this event.The labeling on the device, associated with field modification instructions (fmi) 32070 (fda res 84077; z-0538-2020, z-0539-2020, z-0540-2020, z-0541-2020), was in place, the springs on latches were functional, and all latches were inspected and verified to be secure when fully inserted.The investigation determined that the device functioned as intended, did not malfunction, and met all specifications.The potential root cause for the patient fall from bedside panels is determined as the healthcare professional user either forgot to check the bedside panel latches prior to use with a patient, or they skipped the step unintentionally.

• Brand Name: GIRAFFE OMNIBED CARESTATION
• Type of Device: INCUBATOR, NEONATAL
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11979786
• MDR Text Key: 259454827
• Report Number: 2112667-2021-01495
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K152814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2082844-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 DA
• Patient Weight: 4