GIRAFFE INCUBATOR CARESTATION
Received Jun 5, 2026 · Event occurred May 8, 2026
Report 3036470679-2026-00070 · MDR key 25408654
Device
Generic name
Incubator, Neonatal
Manufacturer
Datex-ohmeda, Inc.Model number
CS1Catalog number
NA
Lot number
NA
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIGNIFICANT DEGRADATION OR LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
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: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED COMPLAINT DID NOT INVOLVE A MALFUNCTION THAT WOULD LEAD TO LOSS OF OXYGEN THERAPY. THERE WAS NO REPORTABLE MALFUNCTION.