MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GIRAFFE WARMER; WARMER, INFANT RADIANT

Model Number M1118179

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skull Fracture (2077)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

On 02-jun-2020 ge healthcare (gehc) was notified by (b)(6) hospital in (b)(6) that a (b)(6) old, ((b)(6) at birth) male was discovered on the floor by cleaning staff.Based on our investigation and thorough examination of the device, gehc concluded that the device was functioning as intended, did not malfunction, and met all specifications.Ge healthcare does not believe that the device caused or contributed to the patient fall.Based on information provided by the hospital: no one observed the patient fall.Imaging tests were performed, and it was found that the patient had a fractured skull.No cerebellar bleed was identified.To date, no additional clinical interventions have been necessary due to the fall.The hospital placed the device back into service the day after the incident occurred.An investigation of the handling of the patient and workflow is ongoing at the customer site.A follow-up report will be issued when the investigation has been completed.The ge field engineer thoroughly examined the device in question within 48 hours of being informed of the incident: the device was thoroughly examined, including but not limited to a thorough examination of all device walls, wall latches, bed assembly, and overall functionality of the device.The device was found to meet all specifications and no device malfunction or breakage was found.The field engineer also confirmed that all labeling associated with fmi (b)(4) ((b)(4)), including device labels and posters were present and appropriately applied per fmi (b)(4) instructions.

Event Description

On 02-jun-2020 ge healthcare (gehc) was notified by a hospital in (b)(6) that a (b)(6) old, ((b)(6) at birth) male was discovered on the floor by cleaning staff.Based on our investigation and thorough examination of the device, gehc concluded that the device was functioning as intended, did not malfunction, and met all specifications.Ge healthcare does not believe that the device caused or contributed to the patient fall.

Manufacturer Narrative

The hospital provided limited information to ge healthcare (gehc).The hospital was unable to confirm if the walls were locked properly at the time of the event and further indicated they could not rule out a mistake made by the hospital staff leading to the patient event.At the request of the hospital, gehc engineering evaluated the potential failure mode of infant fall due to a baby coming in contact with the wall and pushing it upwards.The analysis indicated that the force required to lift the wall is greater than the possible force a baby with 27-week gestation would be able to apply to lift and unlatch the wall.Based on our investigation and thorough examination of the device, gehc concluded that the device was functioning as intended, did not malfunction, and met all specifications.

• Brand Name: GIRAFFE WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 10201306
• MDR Text Key: 198285961
• Report Number: 2112667-2020-01799
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K122267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1118179
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 127 DA
• Patient Weight: 3