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	04/13/2026
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: gehc trout, 3114 n grandview blvd, usa, waukesha, wi 53188.
Event or Problem Description
This unit was identified as having an issue with the heater door that indicates it may be impacted by the issue being addressed as part of correction and removal initiated by ge healthcare (gehc) on 22-oct-2024 (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: 25124440
• Report Number: 3008729547-2026-00038
• Device Sequence Number: 15618566
• Product Code: FMZ
• UDI-Device Identifier: 00840682116862
• UDI-Public: (01)00840682116862(11)221126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 04/13/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2022
• 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