DeVilbiss 7314P-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00885304000327), received between Feb 9, 2022 and Jun 16, 2023 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (49 reports).

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

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148254 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138876 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "UNIT HAS NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136438 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136340 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136166 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "ITEM ISN'T CREATING ENOUGH 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135287 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134662 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134510 ↗
• MalfunctionJun 15, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "UNIT HAS NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134401 ↗
• MalfunctionJun 8, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086262 ↗
• MalfunctionJun 7, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082933 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021771 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021387 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019872 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "UNIT HAS NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019736 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019481 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER AND A LOOSE MANIFOLD. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019301 ↗
• MalfunctionMay 26, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "UNIT HAS NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS ADDRESSED CHECK VALVE COMPLAINTS VIA CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010848 ↗
• MalfunctionApr 27, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827209 ↗
• MalfunctionApr 27, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY AN END USER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827036 ↗
• MalfunctionApr 27, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825852 ↗
• MalfunctionApr 27, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825604 ↗
• MalfunctionApr 27, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE, WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825451 ↗
• MalfunctionApr 25, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT HAS "NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809919 ↗
• MalfunctionApr 14, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT HAS] NO 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 SPECIFICATION. THE ROOT CAUSE WAS THE UMBRELLA-STYLE CHECK VALVE THAT DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS A CAPA FOR THE CHECK VALVE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744987 ↗

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 · Terminated
  DeVilbiss Model 7305P-D Powered Suction Unit
• Z-2319-2013 · Mar 7, 2013 · Terminated
  DeVilbiss 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 · Terminated
  DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.