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

Model Number	CS1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ge healthcare (gehc) reported a field modification for this heater door issue per 21 cfr 806 on 22-oct-2024.The fda recall number is z-0047-2025 & z-0048-2025.Customers were sent a letter explaining the issue and instructions for inspecting, installing, and tightening the screw that secures the heater door.Gehc will replace all affected units.Block a: no report of patient involvement.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.
Event or Problem Description
As a result of an inspection that was completed as part of correction and removal initiated by ge healthcare (gehc) on 22-oct-2024 (recall no.Z-0047-2025 & z-0048-2025), this unit was identified as having an issue with the heater door that indicates it may be impacted by the issue described in the recall no.Z-0047-2025 & z-0048-2025.There was no patient involvement.

• Brand Name: GIRAFFE OMNIBED 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: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 24615549
• Report Number: 3008729547-2026-00022
• Device Sequence Number: 16035734
• Product Code: FMZ
• UDI-Device Identifier: 00840682116862
• UDI-Public: (01)00840682116862(11)240802
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213551
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 02/17/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0047-2025 & Z-0048-202
• Patient Sequence Number: 1
• Patient Sex: Unknown