DeVilbiss 7305P-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00885304002369), received between Mar 15, 2022 and Jun 15, 2023 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (22 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 45 reports, in the reporter's own words as published by the FDA.

• 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 17137775 ↗
• MalfunctionJun 5, 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 17064741 ↗
• MalfunctionMay 30, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE "[UNIT IS] NOT SUCTIONING." 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 17022375 ↗
• MalfunctionApr 28, 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 16831764 ↗
• MalfunctionApr 28, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THAT THE "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 THE MINIMUM 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 16831564 ↗
• MalfunctionApr 28, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THE UNIT WAS "NOT SUCTIONING." 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 16831460 ↗
• MalfunctionApr 14, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THAT 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 THE MINIMUM 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 16746044 ↗
• 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 16745123 ↗
• MalfunctionMar 17, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A PROVIDER, WHO STATED THAT 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 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 16567419 ↗
• MalfunctionFeb 21, 2023Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT OF "NO SUCTION" INVOLVING A DEVILBISS SUCTION DEVICE. 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 OF THE LOW SUCTION CONDITION WAS THE UMBRELLA VALVE HAVING DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH THE VALVE/CYLINDER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407766 ↗
• MalfunctionJan 9, 2023Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "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 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 16122164 ↗
• MalfunctionJan 9, 2023Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "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 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 16122128 ↗
• MalfunctionJan 6, 2023Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT WAS "NOT SUCTIONING." 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 A LOOSE MANIFOLD. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112848 ↗
• MalfunctionDec 15, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "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 THE MINIMUM SPECIFICATION. THE ROOT CAUSE WAS DETERMINED TO BE THE UMBRELLA-STYLE CHECK VALVE THAT HAD DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986449 ↗
• MalfunctionDec 15, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. 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 15986415 ↗
• MalfunctionDec 5, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT "WILL NOT SUCTION AT ALL." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A LOOSE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916692 ↗
• MalfunctionDec 5, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT "WILL NOT SUCTION AT ALL." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. 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 15916651 ↗
• MalfunctionDec 5, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. 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 15916497 ↗
• MalfunctionNov 30, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. 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 15887562 ↗
• MalfunctionNov 28, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. 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 15869159 ↗
• MalfunctionNov 28, 2022Suction Failure; Suction Failure

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A SUCTION UNIT BY A DISTRIBUTOR, WHO STATED THAT THE UNIT HAD "NO SUCTION." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED AND EVALUATED AND FAILED INITIAL SUCTION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE AN UMBRELLA-STYLE CHECK VALVE THAT HAD DISLODGED FROM THE COMPRESSOR CYLINDER. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH VALVE/CYLINDER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868921 ↗
• MalfunctionSep 1, 2022Failure to Power Up; Failure to Power Up

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT OF "NOT WORKING, WILL NOT TURN ON AT ALL" INVOLVING A DEVILBISS SUCTION DEVICE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE ROOT CAUSE OF THE LOW SUCTION CONDITION WAS BATTERY LOW VOLTAGE. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339436 ↗
• MalfunctionSep 1, 2022Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A SUCTION UNIT THAT HAS "LOW PRESSURE." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE CAUSE OF THE LOW-PRESSURE COMPLAINT WAS CORROSION OF THE MOTOR, WHICH WAS THE RESULT BY BACK-SUCTION OF FLUID INTO THE UNIT. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338254 ↗
• MalfunctionAug 16, 2022Decrease in Pressure; Decrease in Pressure

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT OF "LOW SUCTION" INVOLVING A DEVILBISS SUCTION DEVICE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE ROOT CAUSE OF THE FAILURE MODE WAS BACK-SUCTION OF EVACUATED CONTENTS INTO THE UNIT, RENDERING IT UNREPAIRABLE. THIS CONDITION IS THE RESULT OF FAILING TO OPERATE THE DEVICE AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234340 ↗
• MalfunctionAug 16, 2022Decrease in Pressure; Decrease in Pressure

  DEVILBISS HEALTHCARE RECEIVED A COMPLAINT OF "LOW SUCTION" INVOLVING A DEVILBISS SUCTION DEVICE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION. THE ROOT CAUSE OF THE FAILURE MODE WAS BACK-SUCTION OF EVACUATED CONTENTS INTO THE UNIT, RENDERING IT UNREPAIRABLE. THIS CONDITION IS THE RESULT OF FAILING TO OPERATE THE DEVICE AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233485 ↗

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.