VITAL SIGNS¿ HEAD POSITIONER
Received Sep 24, 2021 · Event occurred Aug 24, 2021
Report 3013421741-2021-00002 · MDR key 12530278
Device
Generic name
Support, Patient Position
Model number
VITAL SIGNS¿ HEAD POSITIONERCatalog number
8000HDP
Lot number
53748741
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONFIRMED THAT THE PRODUCT SAMPLE AND PHOTO ARE NOT AVAILABLE FOR ANALYSIS. HOWEVER, THE LOT NUMBER WAS PROVIDED TO CONDUCT A DEVICE HISTORY RECORD REVIEW. THE ISSUE OCCURRED WITH TWO PATIENTS. PLEASE REFER TO (B)(4) FOR THE OTHER PATIENT. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER SPLIT INTO TWO WHILE ON PATIENT USE, HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO HARM ON A PATIENT.