DeVilbiss 7314D-DRecalls & reported problems
Devilbiss Healthcare LLC · Vacu-Aide QSU, North America · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304000587), received between Mar 23, 2023 and Mar 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K982304); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2023Suction Problem; Suction Problem
DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THAT THE UNIT HAS "WILL NOT SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED TO DEVILBISS FOR EVALUATION, WHERE IT WAS DETERMINED THE UNIT WAS UNABLE TO PRODUCE VACUUM PRESSURE TO THE MINIMUM SPECIFICATION. THE ROOT CAUSE WAS DETERMINED TO BE AN UMBRELLA-STYLE CHECK VALVE THAT HAD DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16602968 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982304. One submission often covers many models, so check the product and lot details in each record.
- Z-2246-2016 · May 23, 2016 · TerminatedDeVilbiss Model 7305P-D Powered Suction Unit
- Z-2319-2013 · Mar 7, 2013 · TerminatedDeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container
- Z-0863-2009 · Oct 27, 2008 · TerminatedDeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.
Other Apparatus, Suction, Ward Use, Portable, Ac-Powered devices
- Penumbra System PMX110Penumbra, Inc. · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED166 reports
- IntelliCart™ 00514010400Zimmer Orthopaedic Surgical Products, Inc. · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED112 reports
- Penumbra System PMX220Penumbra, Inc. · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED102 reports
- DeVilbiss 7314P-DDevilbiss Healthcare LLC · Apparatus, Suction, Ward Use, Portable, Ac-Powered69 reports
- PIRANHA 2208011Richard Wolf GmbH · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED54 reports
- LCSU 4, 300 ml, RTCA Complete Unit 880062Laerdal Medical AS · Apparatus, Suction, Ward Use, Portable, Ac-Powered1 recall0 reports
- LCSU 4, 800 ml, RTCA Complete Unit 880052Laerdal Medical AS · Apparatus, Suction, Ward Use, Portable, Ac-Powered1 recall0 reports
- Neptune 0770100000Stryker Corporation · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.