InjuryCCX
VITAL SIGNS HEAD POSITIONER
Received Feb 28, 2020 · Event occurred Jan 15, 2020
Report 9613793-2020-00008 · MDR key 9771461
Device
Generic name
Support, Patient Position
Manufacturer
Vyaire Medical.Model number
VITAL SIGNS¿ HEAD POSITIONERCatalog number
8000HDP
Lot number
49797348
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT THE PRODUCT SAMPLE AND PHOTO IS AVAILABLE FOR ANALYSIS. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT SURGERY WHILE USING THE VITAL SIGNS HEAD POSITIONER. AFTER THE LONG PROCEDURE, THE PATIENT WAS DISCOVERED TO HAVE BURNS AND ULCERS AROUND THE JAW.