MAUDE Adverse Event Report: Critikon de Mexico S. de R.L. de C.V. Giraffe; Warmer, Infant Radiant

Model Number	Warmer
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a malfunction during pre-use checkout resulting in unavailable oxygen therapy.There was no patient involvement.
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.Block a: no report of patient involvement.Legal manufacturer: gehc trout - 3114 n grandview blvd.Usa waukesha, wi 53188.

• Brand Name: Giraffe
• Common Device Name: Warmer, Infant Radiant
• 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: 50867675
• Report Number: 3008729547-2026-00087
• Device Sequence Number: 16120848
• Product Code: FMT
• UDI-Device Identifier: 00840682103923
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K201628
• 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
• Report Date (Section B): 09/23/2026

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: Warmer
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown