PUSH TO SET VACUUM REGULATOR
Received Feb 18, 2025
Report 1419185-2024-00003 · MDR key 21393218
Device
Product problems
- Unexpected Therapeutic Results
- Unexpected Therapeutic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON RECEIPT OF MEDWATCH FORM 3500A COMPLAINT RECORDS WERE REVIEWED. IT WAS DETERMINED THAT COMPLAINT HAD NOT BEEN REPORTED DIRECTLY TO OHIO MEDICAL, THEREFORE USER FACILITY WAS CONTACTED FOR ADDITIONAL INFORMATION. DEVICE HAS SINCE BEEN RETURNED TO MANUFACTURER; HOWEVER EVALUATION CANNOT BE COMPLETE DUE TO NOT HAVING ASSURANCE/EVIDENCE FROM THE USER FACILITY THAT DEVICE IS FREE FROM CONTAMINATION. OHIO MEDICAL WILL CONTINUE TO ATTEMPT TO OBTAIN THIS EVIDENCE SO THAT FULL EVALUATION CAN BE PERFORMED AND FOLLOW UP REPORT WILL BE SUBMITTED UPON THAT EVALUATION.
Description of Event or Problem
USER FACILITY REPORT (B)(4) WAS RECEIVED AND CASE WAS INITIATED ON (B)(6) 2024 STATING "VACUUM REGULATOR NOT ADJUSTING APPROPRIATELY. GOES TO FULL VACUUM WHEN IT APPEARS TO BE SET TO LOW."