MalfunctionFMT
GIRAFFE
Received Jun 24, 2026 · Event occurred May 27, 2026
Report 3036470679-2026-00090 · MDR key 25607883
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Datex-ohmeda, Inc.Model number
WARMERCatalog number
NA
Lot number
NA
Product problems
- Break
Patient
Not reported
- 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 SIDE PANEL WAS ORDERED FOR REPLACEMENT TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Description of Event or Problem
IT WAS REPORTED THAT THE SIDE PANEL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.