HEAD ADAPTER BRACKET
Received Apr 12, 2023 · Event occurred Mar 27, 2023
Report 16723468 · MDR key 16723468
Device
Generic name
Holder, Head, Radiographic
Manufacturer
Hill-rom Company, Inc.Catalog number
216054
Lot number
22-028
Product problems
- Patient Device Interaction Problem
Patient
22630 DA · Male
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
PATIENT WAS INTUBATED AND THE CARE TEAM DECIDED TO FLIP TO PATIENT INTO A PRONE POSITION, AND WHEN THE PATIENT WAS MOVED INTO THE PRONE POSITION, STAFF USED THE "HILL-ROM HEAD POSITIONER" AND "HEAD ADAPTER BRACKET" TO SUPPORT THE PATIENTS HEAD AND NECK WHILE PRONING THE PATIENT. AFTER APPROXIMATELY 12-16 HOURS OF BEING IN THE PRONE POSITION, STAFF BEGAN TO PUT THE PATIENT BACK INTO THE SUPINE POSITION, AND THEY REALIZED THAT THE PATIENT HAD DEVELOPED SORES ON BOTH OF HIS CHEEKS WHERE THE PATIENT¿S SKIN WAS IN CONTACT WITH THE "HILL-ROM HEAD POSITIONER." NURSING STAFF TREATED THE SORES AND REPORTED THE PROBLEM TO THEIR MANAGER. MANUFACTURER RESPONSE FOR HEAD ADAPTER BRACKET, (BRAND NOT PROVIDED) (PER SITE REPORTER): ICU NURSE MANAGER HAS REACHED OUT TO THE HILL ROM REP, BUT HAS NOT HEARD ANYTHING BACK AFTER NUMEROUS ATTEMPTS TO CONTACT HER.