MalfunctionFMT
Panda
Received Jul 30, 2026 · Event occurred Jul 2, 2026
Report 3036470679-2026-00124 · MDR key 50082663
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
i-Res Warmer 1.0Catalog number
NA
Lot number
NA
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the front panel was broken. There was no patient involvement reported.
Additional Manufacturer Narrative
A GE HealthCare Service Representative performed a checkout of the system and confirmed the reported issue. The front panel 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.