Pneupac P200DNUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 35019315072738), received between Dec 21, 2023 and Mar 4, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (6 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT SEEMED TO HAVE AIR LEAK. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514685 ↗
• MalfunctionDec 31, 2024Medical Gas Supply Problem; Medical Gas Supply Problem

  IT WAS REPORTED THAT EVEN WHEN THE AIR MIX WAS SET TO 45, IT STILL FLOWED AT 100. THE FAULT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047953 ↗
• MalfunctionDec 31, 2024Medical Gas Supply Problem; Medical Gas Supply Problem

  IT WAS REPORTED THAT WHEN THE AIR MIX WAS SET TO 45%, THE OXYGEN CONCENTRATION BECAME 60%. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047667 ↗
• MalfunctionOct 18, 2024Tidal Volume Fluctuations; Tidal Volume Fluctuations

  IT WAS REPORTED THAT WITH THE DEVICE THERE WAS A LARGE DIFFERENCE IN TIDAL VOLUME. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487113 ↗
• MalfunctionSep 20, 2024Mechanical Problem; Decrease in Pressure; Mechanical Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE PRESSURE DOESN'T INCREASE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273372 ↗
• MalfunctionJul 19, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A SUSPECTED LEAK. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784222 ↗
• MalfunctionJun 19, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD A CONTINUOUS LOW PRESSURE ALARM EVEN WHEN THE SWITCH WAS TURNED OFF. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570397 ↗
• MalfunctionJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PRODUCT WASN'T WORKING. EVENT OCCURRED BEFORE PATIENT USE, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510678 ↗
• MalfunctionJun 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ELECTRONIC ALARM KEEPS RINGING WHEN DRIVING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510677 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE SWITCH COVER. THE FAULT OCCURRED BEFORE IN USE WITH THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510676 ↗
• MalfunctionJun 10, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE TIMING OF THE LOW-PRESSURE ALARM IS DIFFERENT FROM BEFORE. THE EVENT HAPPENED DURING INSPECTION IN THE ME ROOM, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497913 ↗
• MalfunctionJun 5, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BREATHING RATE KNOB IS DAMAGED. THE OXYGEN CONCENTRATION KNOB COMES OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473260 ↗
• MalfunctionMay 13, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PRODUCT HAD A PROBLEM WITH THE BATTERY LEVEL LAMP. EVENT OCCURRED BEFORE PATIENT USE, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305451 ↗
• MalfunctionMay 13, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ALARM FOR MUTE/SILENT LAMP LIT UP DURING TESTING. EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305409 ↗
• MalfunctionMay 13, 2024Device Alarm System; Battery Problem; Device Alarm System; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DISPLAY BLINKS EVEN AFTER REPLACING THE BATTERY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297299 ↗
• MalfunctionApr 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT HAS AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164757 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN OXYGEN LEAK. THE FAULT OCCURRED BEFORE IN USE WITH THE PATIENT. THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152973 ↗
• MalfunctionApr 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015553 ↗
• MalfunctionMar 26, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE PRODUCT'S LOW-PRESSURE ALARM KEPT SOUNDING EVEN THOUGH IT WAS IN A DEMAND STATE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981653 ↗
• MalfunctionMar 7, 2024Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  IT WAS STATED THAT PARTS OF THE DISPOSABLE BREATHING CIRCUIT OUTLET ARE MISSING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861314 ↗
• MalfunctionFeb 19, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE ISSUE IS DUE TO MISSING CIRCUIT CONNECTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18735713 ↗
• MalfunctionFeb 8, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE POWER ALARM DID NOT GO OFF PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669663 ↗
• MalfunctionDec 27, 2023No Device Output; No Flow; No Device Output; No Flow

  IT WAS REPORTED THAT DURING PATIENT USE THERE WAS NO VENTILATION. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402540 ↗
• MalfunctionDec 27, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE DEVICE HAD A CONTINUOUS FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402469 ↗
• MalfunctionDec 27, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATENT USE THE DEVICE HAD AN OXYGEN LEAK. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402448 ↗