MalfunctionFMT
PANDA
Received Feb 27, 2026 · Event occurred Jan 30, 2026
Report 3036470679-2026-00015 · MDR key 24469021
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
I-RES WARMER 1.0Catalog number
NA
Lot number
NA
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE UNIT 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.
Description of Event or Problem
IT WAS REPORTED THAT THE SIDE PANEL WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.