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

Model Number	i-Res Warmer 1.0
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a malfunction during service causing loss of oxygen concentration.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 check valve assembly was replaced to resolve the issue.Block a: no report of patient involvement.Legal manufacturer: gehc trout - 3114 n grandview blvd.Usa waukesha, wi 53188.

• Brand Name: Panda
• 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: 50817298
• Report Number: 3008729547-2026-00083
• Device Sequence Number: 10677128
• Product Code: FMT
• UDI-Device Identifier: 00840682152709
• UDI-Public: (01)00840682152709(11)241221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2024
• 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