CARE PLUS
Received Mar 12, 2026 · Event occurred Feb 11, 2026
Report 3005860720-2026-00001 · MDR key 24579630
Device
Generic name
Incubator, Neonatal
Catalog number
NA
Lot number
NA
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE UNIT WAS AT END OF SERVICE LIFE. THERE WAS NO REPAIR. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. BLOCK H4: DATE OF DEVICE MANUFACTURE YEAR IS 2004. THE MONTH OF MANUFACTURE WAS UNAVAILABLE AT TIME OF MDR FILING. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.