inforMED
MalfunctionKDP

OHIO MEDICAL VACUUM REGULATOR

Received Aug 25, 2025 · Event occurred Apr 12, 2025

Report 22886384 · MDR key 22886384

Device

Generic name

Regulator, Vacuum

Manufacturer

Ohio Medical Llc

Model number

PISA

Product problems

  • Failure to Cycle
  • Unintended System Motion
  • Increase in Suction

Patient

54 YR · Unknown

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

Narrative

Description of Event or Problem

VACCUM REGULATOR, HAD SELECTOR SWITCH TO SET TO INTERMITTENT SUCTION SETTING. OBSERVED REGULATOR NOT RELEASING SUCTION.