MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. GIRAFFE INCUBATOR CARESTATION; INCUBATOR, NEONATAL

Model Number	CS1
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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 a malfunction resulting in loss of auxiliary oxygen.There was no patient involvement.
Additional Manufacturer Narrative
The customer declined ge healthcare service.No repair information available.

• Brand Name: GIRAFFE INCUBATOR CARESTATION
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 22952632
• Report Number: 3008729547-2025-00085
• Device Sequence Number: 13140390
• Product Code: FMZ
• UDI-Device Identifier: 00840682116855
• UDI-Public: (01)00840682116855(11)230121
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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?: No
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2023
• 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