SOMNOSTAR
Received Nov 1, 2022 · Event occurred Oct 5, 2022
Report 2021710-2022-16801 · MDR key 15710024
Device
Generic name
Standard Polysomnograph With Electroencephalograph
Manufacturer
Vyaire Medical Inc.Model number
SOMNOSTAR Z4 SYSTEM VER 11Catalog number
28483-001
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS AN ARTIFACT IN THE STUDY ON THE SOMNOSTAR Z4 SYSTEM VER 11 .THE PATIENT WAS SENT HOME DUE TO THE ARTIFACT.THE IMPEDANCE WAS GOOD. THE STUDY STARTED FINE AND AFTER AN HOUR THEY NOTICED THE ARTIFACT AND THEY SENT THE PATIENT HOME. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION.THE REPORTED COMPLAINT WAS NOT CONFIRMED OR DUPLICATED. THE UUT'S(UNIT UNDER TEST) WERE TESTED AND FOUND TO BE FUNCTIONING AS INTENDED.