C-FLEX POLAR HEAD POSITIONER
Received Jun 2, 2026 · Event occurred May 6, 2026
Report 3006697241-2026-00207 · MDR key 25364168
Device
Generic name
C-flex Head Positioning System
Manufacturer
Baxter Healthcare CorporationModel number
A-70715Catalog number
A-70715
Lot number
N/A
Product problems
- Positioning Failure
- Unstable
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING THE COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
BAXTER RECEIVED A REPORT THAT CFLEX PRON FACE MASK HD MOD HAD HEADREST UNSTABLE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.