MAUDE Adverse Event Report: OHIO MEDICAL LLC PUSH TO SET VACUUM REGULATOR

Model Number	PISA
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.".

• Brand Name: 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
• MDR Report Key: 21393218
• Report Number: 1419185-2024-00003
• Device Sequence Number: 8273529
• Product Code: KDP
• UDI-Device Identifier: 08688250002085
• UDI-Public: 08688250002085
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: PISA
• Device Catalogue Number: 8701-1251-908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• 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