Pneupac V200DNUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 35019315074183), received between Dec 12, 2018 and Jun 24, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE GAUGE WAS NOT GOING PAST 0 OR DELIVERING BREATHS. ALSO, IT WAS REPORTED THERE WAS NO PHYSICAL DAMAGE, AND THE UNIT WAS NOT DROPPED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601232 ↗
• MalfunctionMar 7, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE HAD A BROKEN AIR MIX KNOB. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16499521 ↗
• MalfunctionSep 12, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE DOES NOT TURN ON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401508 ↗
• MalfunctionSep 7, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT DETECT BREATHING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371020 ↗
• MalfunctionAug 2, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITH MEDICAL VENTILATORS/PNEUPAC VENTILATORS VENTIPAC MALFUNCTIONED. REPORTED AIR IS LEAKING AND GAUGE IS OFF. INSPIRATORY KNOB IS CATCHING ON SOMETHING. EVENT OCCURRED DURING TESTING AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263609 ↗
• MalfunctionAug 2, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITH MEDICAL VENTILATORS/PNEUPAC VENTILATORS VENTIPAC MALFUNCTIONED. REPORTED AIR IS LEAKING AND GAUGE IS OFF. INSPIRATORY KNOB IS CATCHING ON SOMETHING. EVENT OCCURRED DURING TESTING AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12262416 ↗
• MalfunctionMay 7, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FLOW ON A SMITHS MEDICAL VENTILATOR DID NOT HAD PROPER LEVELS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11794697 ↗
• MalfunctionApr 8, 2021Difficult to Open or Close; Difficult to Open or Close

  RO 1134976: BATTERY DOOR NOT LATCHING.

  Patient problems: Insufficient Information

  MAUDE report 11632368 ↗
• MalfunctionDec 30, 2020Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE VENTILATOR PRODUCED THE FOLLOWING ERROR/ALARM: NO PRESSURE DISCONNECT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 11096404 ↗
• MalfunctionMay 20, 2020Loose or Intermittent Connection; Component Missing; Loose or Intermittent Connection; Component Missing

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR WAS DROPPED CAUSING THE KNOBS TO NOT MAKE CONTACT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Information

  MAUDE report 10075106 ↗
• MalfunctionApr 16, 2020Failure to Power Up; Failure to Power Up

  RO 1056257: IT DOESN'T TURN ON.

  Patient problems: No Information

  MAUDE report 9970019 ↗
• MalfunctionFeb 28, 2020Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  INFORMATION WAS RECEIVED THAT INCIDENT OCCURED DURING INSPECTION; NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9771679 ↗
• MalfunctionSep 22, 2019Failure to Cycle; Display or Visual Feedback Problem; Failure to Cycle; Display or Visual Feedback Problem

  INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS VENTIPAC .

  Patient problems: No Information

  MAUDE report 9101417 ↗
• MalfunctionSep 9, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTIPAC VENTILATOR ALARMS. NO ADVERSE EFFECTS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8976083 ↗
• MalfunctionSep 9, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTIPAC VENTILATOR ALARMS. NO ADVERSE EFFECTS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8976080 ↗
• MalfunctionJul 16, 2019Use of Device Problem; Component Missing; Material Twisted/Bent; Use of Device Problem; Component Missing; Material Twisted/Bent

  IT WAS REPORTED THAT THE PNEUPAC WAS STUCK. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796305 ↗
• MalfunctionDec 12, 2018Unable to Obtain Readings; Unable to Obtain Readings

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTIPAC MEDICAL VENTILATOR HAD A DAMAGED GAUGE READING. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156965 ↗