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

Model Number	PISA
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint case (b)(4) was initiated due to medsun report being received (b)(4) stating the following: describe the event or problem: suction head was found to be on the high setting.Suction was not working on low setting, attempted to fix.Suction head either to be set at none or high/full.Switched with 5 other suction heads with similar issues.What was the original intended procedure? suction delivery at low setting.What problem did the use have? device failed (e.G.Broke, couldn't get it or work or stopped working).
Additional Manufacturer Narrative
As of today, 09/25/2026 user facility has been unable to locate device for return and evaluation.Upon return this investigation will be supplemented with evaluation results.

• Brand Name: Push To Set Ohio Medical 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
• MDR Report Key: 50901700
• Report Number: 1419185-2026-00003
• Device Sequence Number: 10761681
• Product Code: KDP
• UDI-Device Identifier: 08688250002085
• UDI-Public: 010868825000208521PSAX10743
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 8705-1251-901
• Device Lot Number: PISA18117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2018
• Is the Device Labeled for Single Use? (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: 66 YR
• Patient Sex: Male