VITAL SIGNS¿ HEAD POSITIONER
Received Jun 25, 2022 · Event occurred Sep 11, 2019
Report 3013421741-2022-00014 · MDR key 14811887
Device
Generic name
Support, Patient Position
Manufacturer
Vyaire MedicalModel number
VITAL SIGNS¿ HEAD POSITIONERCatalog number
8000HDP
Lot number
00048523724
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Unknown
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). NO PHOTOGRAPHIC EVIDENCE WAS SUPPLIED AND NO SAMPLE WAS RETURNED. THE DEVICE USED ON THE PATIENT WAS DISCARDED AND THEREFORE THE REPORTED DEFECT COULD NOT BE CONFIRMED. 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 THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER CAUSED PRESSURE WOUND TO A PATIENT WHEN USED. THE BURNS WERE SEEN ON THE FOREHEAD NEAR THE EYEBROWS. THE CUSTOMER REPORTED IT IS A PRESSURE WOUND THAT CAUSED MULTIPLE BURN WOUNDS ON THE FACE WITH BREAKAGE OF THE SKIN.