VITAL SIGNS¿ HEAD POSITIONER
Received Mar 22, 2023 · Event occurred Feb 15, 2023
Report 3010838917-2023-00048 · MDR key 16591676
Device
Generic name
Support, Patient Position
Manufacturer
Vyaire Medical Inc.Model number
VITAL SIGNS¿ HEAD POSITIONERCatalog number
8000HDP
Lot number
57973735
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: DURING THE INVESTIGATION PROCESS, THE DEVICE HISTORY RECORD WAS REVIEWED FOR ANY DISCREPANCIES THAT MIGHT HAVE OCCURRED DURING PRODUCTION TO EXPLAIN THE ISSUE REPORTED, NOTHING WAS FOUND. CURRENT INVENTORY WAS EVALUATED FOR ANY MANUFACTURING DEFECTS; NO ERRORS OR DISCREPANCIES WERE FOUND. DUE TO THE LACK OF A DEFECTIVE SAMPLE AND THE LIMITED INFORMATION PROVIDED, THE ISSUE COULD NOT BE CONFIRMED, AND A ROOT CAUSE WAS NOT DETERMINED.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING A PROCEDURE, A CRACK WAS OBSERVED ON THE PRONE HEAD POSITIONER WITH MIRROR. THE DEVICE WAS ON THE PATIENT BUT NO HARM OCCURRED AND NO INTERVENTION WAS NEEDED.
Additional Manufacturer Narrative
VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.