VITAL SIGNS¿ HEAD POSITIONER
Received Sep 29, 2023 · Event occurred Jan 1, 2023
Report 3013421741-2023-00038 · MDR key 17844563
Device
Generic name
Support, Patient Position
Manufacturer
Vyaire Medical Inc.Model number
PRONE HEAD POSITIONER WITH MIRRORCatalog number
8000HDP
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Unknown
- Abrasion
- Ulcer
- Abrasion
- Ulcer
Narrative
Additional Manufacturer Narrative
H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. ON FOLLOW-UP, THE CUSTOMER INDICATED THAT THEY DO NOT HAVE SUSPECT SAMPLES AVAILABLE BECAUSE, AFTER USE, ALL THE DEVICES WERE DISPOSED OF. ALSO, THE CUSTOMER CONFIRMED THAT FROM (B)(6) 2023, ABOUT 40-45 PIECES WERE USED BUT WAS NOT ABLE TO INDICATE THE LOT NUMBERS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WERE SIGNS OF DECUBITUS ON THE FACE AFTER PRONE-POSITION SURGERY. ACCORDING TO THE NEUROSURGEONS, THE VITAL SIGNS¿ HEAD POSITIONER OFTEN CAUSES REDNESS ON THE MOST EXPOSED PARTS OF THE PATIENT'S FACE, WHICH THEN DEVELOPS INTO ABRASIONS AND PRESSURE INJURIES. THE REDNESS PRESSURE SORES WERE DISCOVERED AT THE END OF THE SURGICAL PROCEDURE, AFTER USE OF THE POSITIONER.