MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. INCUBATOR C2000; INCUBATOR, INFANT, STATIONARY

Model Number	C2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a registered nurse (rn) at the customer site was prompted to the patient's room after hearing the patent's mother in distress.Upon entering the room, the rn found the patient's mother picking up the patient from the floor directly in front of the incubator.The patient's mother alleged that the incubator back door was not locked and that the incubator door fell open and the patient fell from the incubator onto the floor.There were no witnesses in the room with the mother when the incident occurred.The patient was diagnosed with a hematoma to the top right back of the head.Treatment from the emergency room physician and rn was administered, and it was decided to medevac the patient to a higher level of care for further assessment.The device was confirmed to be in working order as designed at the time of the event.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
The patient's weight was provided (3.48kg); however the customer declined to provide other patient information (i.E.Initials, gender, status).At the time of the event, the device was sequestered and professional engineers from northwest territories health and social services authority were contacted to investigate the device/incident.During validation testing it was confirmed that no malfunction was identified and that the device was safe to return to service.The incubator c2000 instructions for use (ifu) provides the following in the "hood/shell functional checkout" procedure under "check the access panels" - "close the access panel, and rotate both latches until fully engaged; at the controller screen, check that the access panel open symbol turns off." caution - risk of injury - both locking knobs must be fully engaged to avoid accidental opening of the panels; warning - risk of death or serious injury - positively secure all hand port latches and access panel locking knobs to avoid accidental opening; warning - risk of death or serious injury - for infant safety, do not leave the infant unattended when the access panels or hand ports are open.Of note, the access (port) doors are designed to withstand a horizontal force of 2.0 - 2.5kg (20 - 25n).H3 other text : see h10.
Event or Problem Description
It was reported that a registered nurse (rn) at the customer site was prompted to the patient's room after hearing the patent's mother in distress.Upon entering the room, the rn found the patient's mother picking up the patient from the floor directly in front of the incubator.The patient's mother alleged that the incubator back door was not locked and that the incubator door fell open and the patient fell from the incubator onto the floor.There were no witnesses in the room with the mother when the incident occurred.The patient was diagnosed with a hematoma to the top right back of the head.Treatment from the emergency room physician and rn was administered, and it was decided to medevac the patient to a higher level of care for further assessment.The device was confirmed to be in working order as designed at the time of the event.

• Brand Name: INCUBATOR C2000
• Common Device Name: INCUBATOR, INFANT, STATIONARY
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 14196884
• Report Number: 2510954-2022-00002
• Device Sequence Number: 5479756
• Product Code: FMZ
• UDI-Device Identifier: 04049098000222
• UDI-Public: 04049098000222
• Combination Product (Y/N): N
• PMA/510(K) Number: K960980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: C2000
• Device Catalogue Number: MU20500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 3 KG