SUPPORT, PATIENT POSITION
Received Jul 3, 2024 · Event occurred Nov 30, 2023
Report 2921578-2024-00007 · MDR key 19668868
Device
Generic name
Support, Patient Position
Manufacturer
Mizuho Orthopedic Systems, Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Male
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
IT REMAINS UNCLEAR WHICH MIZUHO DEVICES MAY HAVE BEEN INVOLVED IN THE INCIDENT. MIZUHO ORTHOPEDIC SYSTEMS INC. DOES NOT MANUFACTURE ACCESSORIES FOR THE C-FLEX HEAD POSITIONER, AND A REVIEW OF ITS INSTRUCTION MANUAL SUGGESTS IT IS PHYSICALLY INCOMPATIBLE WITH THE MIZUHO OSI FACE PLATE AND/OR PRONE PLATFORM, SO THE IDENTIFICATION MAY HAVE BEEN IN ERROR. THE USER FACILITY WHERE THE EVENT IS SAID TO HAVE OCCURRED HAS NOT RESPONDED TO REQUESTS FOR INFORMATION.
Description of Event or Problem
ALLEN MEDICAL REPORTED (REF NO.MAUDE 3010216206-2023-00008) THAT ONE OF THEIR CUSTOMERS USED THE ALLEN C-FLEX HEAD POSITIONER WITH A MIZUHO FACE MASK PAD AND MIZUHO FACE PLATE. THE PATIENT WAS MALE, HAVING A POSTERIOR CERVICAL SURGERY. HE WAS IN A PRONE POSITION FOR 9 PLUS HOURS. WHEN THE PATIENT WAS TAKEN OUT OF THE POSITIONER, HE HAD DEVELOPED A SEVERE PRESSURE INJURY ON HIS CHIN.