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

Model Number	IRES WARMER
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
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: patient information could not be obtained due to country privacy laws.Legal manufacturer: (b)(4).
Event or Problem Description
It was reported that sparks and a flame occurred at the on/off switch of the unit during a case.The flame was extinguished.There was no patient injury.
Additional Manufacturer Narrative
The most probable root cause of the reported event appears to be the installation of an incorrect, non-rechargeable battery that had been installed in place of the specified ge healthcare rechargeable battery.Use of the unspecified, non-rechargeable battery in the charging circuit led to the battery rupture and the apparition of sparks and flames.According to additionally collected information, the replacement of the battery with an incorrect battery type was done during preventive maintenance that was carried out by a 3rd party service provider.There was no malfunction of the device.

• 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: 23452008
• Report Number: 2112667-2025-08703
• Device Sequence Number: 13021912
• Product Code: FMT
• UDI-Device Identifier: 00840682103893
• UDI-Public: (01)00840682103893(11)200506
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 03/19/2026

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: 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: 10/06/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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