MalfunctionFMT
GIRAFFE IRS
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 3008729547-2026-00051 · MDR key 25633406
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Critikon De Mexico S. De R.l. De C.v.Catalog number
NA
Lot number
NA
Product problems
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN UNAVAILABLE OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE O2 REGULATOR 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.