MAUDE Adverse Event Report: DATEX-OHMEDA, INC. PANDA; WARMER, INFANT RADIANT

Model Number	I-RES WARMER 1.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a broken side panel.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.A: no report of patient involvement.Legal manufacturer: gehc trout - 3114 n grandview blvd.Usa waukesha, wi 53188.
Additional Manufacturer Narrative
Additional information was received that the failure of the warmer base.The latch / panel was functioning correctly.There was no reportable malfunction.

• Brand Name: PANDA
• Common Device Name: WARMER, INFANT RADIANT
• 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: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 23877048
• Report Number: 2112667-2025-09940
• Device Sequence Number: 4669578
• Product Code: FMT
• UDI-Device Identifier: 00840682152709
• UDI-Public: (01)00840682152709(11)220412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: I-RES WARMER 1.0
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown