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

Model Number	CS1
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint.The sensor housing board was replaced to resolve the issue.Block a: no report of patient involvement.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.
Event or Problem Description
It was reported that there was an error resulting in significant degradation or loss of oxygen therapy.There was no patient involvement.

• Brand Name: GIRAFFE INCUBATOR CARESTATION
• Common Device Name: INCUBATOR, 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: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 22473587
• Report Number: 2112667-2025-05704
• Device Sequence Number: 7853705
• Product Code: FMZ
• UDI-Device Identifier: 00840682116855
• UDI-Public: (01)00840682116855(11)211109
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K152809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown