MalfunctionCCX
SUPPORT, PATIENT POSITION
Received Oct 2, 2019 · Event occurred Jun 19, 2019
Report 9145125 · MDR key 9145125
Device
Generic name
Support, Patient Position
Manufacturer
Cardinal HealthCatalog number
FP-HEADSF
Lot number
195299
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Tissue Damage
- Tissue Damage
Narrative
Description of Event or Problem
HEAD FRAME FOAM POSITIONER WITH SOFT LAYER BY CARDINAL HEALTH HAS BEEN CAUSING BREAKDOWN TO PATIENTS CHINS IN THE OPERATING ROOM IN THE PRONE POSITION FOR GREATER THAN EIGHT HOURS. WE SWITCHED TO THIS PRODUCT FROM A DIFFERENT PRODUCT WITHIN THE LAST YEAR AND PREVIOUSLY HAD NO CASES. WE KNOW OF THREE CASES SINCE THE NEW PRODUCT.