VMAX
Received May 19, 2023 · Event occurred Apr 20, 2023
Report 2021710-2023-17704 · MDR key 16963211
Device
Generic name
Spirometer, Diagnostic
Manufacturer
Vyaire MedicalModel number
INSTRUMENT ASSY V62J AUTOBXCatalog number
773835-101
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS A BURNING SMELL AND THE POWER CABLE MELTED AT ONE OF THE PRONGS ON THE OBS, INSTRUMENT ASSY V62J AUTOBX.THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 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.