MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX VACUUM; VACUUM REGULATOR

Model Number	PID
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: AMVEX VACUUM
• Common Device Name: VACUUM REGULATOR
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031
• MDR Report Key: 21399355
• Report Number: 1419185-2024-00002
• Device Sequence Number: 15780867
• Product Code: KDP
• UDI-Device Identifier: 00628101501389
• UDI-Public: 00628101501389
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PID
• Device Catalogue Number: VR-PIUD-DHD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown