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

Model Number	IRES WARMER
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ge healthcare has 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.
Event or Problem Description
It was reported that there was a malfunction resulting in loss of oxygen therapy.There was no patient involvement.
Additional Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The oxygen hoses were replaced to resolve the issue.

• 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: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 22883418
• Report Number: 2112667-2025-06729
• Device Sequence Number: 18358138
• Product Code: FMT
• UDI-Device Identifier: 00840682103893
• UDI-Public: (01)00840682103893(11)200313
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: IRES WARMER
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• 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