MalfunctionKDP

AMVEX VACUUM

Received Feb 18, 2025 · Event occurred May 3, 2024

Report 1419185-2024-00002 · MDR key 21399355

Device

Generic name

Vacuum Regulator

Manufacturer

Ohio Medical Llc

Model number

PID

Catalog number

VR-PIUD-DHD

Product problems

Unclear Information
Unclear Information

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

USER FACILITY CONTACTED OHIO MEDICAL ON (B)(6) 2024 TO EXPLAIN THAT LABEL ON TOP OF DEVICE DID NOT ALIGN WITH LABEL ON FRONT OF DEVICE (LABEL IDENTIFIES MODE SELECTION).

Additional Manufacturer Narrative

INVESTIGATION INV 2024-05 HAS BEEN INITIATED FOR THIS ISSUE. CUSTOMER FACILITY HAS NOT YET RETURNED DEVICE FOR EVALUATION AFTER THIS NOTIFICATION. ONCE DEVICE IS RECEIVED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED.