MalfunctionFMZ
Giraffe OmniBed Carestation
Received Jul 29, 2026 · Event occurred Jul 1, 2026
Report 3008729547-2026-00059 · MDR key 50068214
Device
Generic name
Incubator, Neonatal
Manufacturer
Critikon De Mexico S. De R.l. De C.v.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that there was a leak malfunction during pre-use checkout resulting in loss of auxiliary oxygen. There was no patient involvement.
Additional Manufacturer Narrative
GE HealthCare¿s investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.Block A: No report of patient involvement. Legal Manufacturer:GEHC Trout - 3114 N Grandview Blvd. USA Waukesha, WI 53188.