MAUDE Adverse Event Report: Ohio Medical LLC Ohio Medical Push To Set Vacuum Regulator

Model Number	PISA
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medsun report (b)(4) was received and complaint case (b)(4) was initiated.Medsun description was as follows: vacuum regulator, had selector switch to set to intermittent suction section setting.Observed regulator not releasing suction.
Additional Manufacturer Narrative
As of today 9/23/2026 we have been unable to obtain returned device or a response from user facility.Upon contact and/or return a supplemental report will be submitted.

• Brand Name: Ohio Medical Push To Set Vacuum Regulator
• Common Device Name: Vacuum Regulator
• Manufacturer (Section D): Ohio Medical LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer (Section G): Ohio Medical LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031 ; +1(847)855-6318
• MDR Report Key: 50881877
• Report Number: 1419185-2026-00002
• Device Sequence Number: 10705272
• Product Code: KDP
• UDI-Device Identifier: 00628101609085
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Model Number: PISA
• Device Catalogue Number: 8701-1251-907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/24/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Unknown