Pneupac P310NUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,035 adverse event reports that list this exact device (DI 35019315107263), received between May 8, 2017 and Sep 29, 2026 — classified as 4 deaths, 13 injuries, 1,018 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (120 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 1,035 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938879 ↗
• MalfunctionSep 2, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569418 ↗
• MalfunctionMay 18, 2026Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE DISPLAYED AN AUDIBLE LOW-PRESSURE ALARM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209979 ↗
• MalfunctionApr 20, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PUMP IS ALARMING LOW PRESSURE DURING PATIENT USE. THERE WAS HARM TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932415 ↗
• MalfunctionMar 2, 2026Intermittent Continuity; Infusion or Flow Problem

  IT WAS REPORTED THAT THE UNIT WAS STUCK IN EXTRAPORY MODE AND WOULD NOT FUNCTION UNLESS IT WAS SHUT OFF, AND THAT THE ISSUE WAS INTERMITTENT AND THE PUMP WAS NOT DROPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488864 ↗
• MalfunctionFeb 27, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE UNIT DID NOT ALLOW PATIENTS TO EXHALE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477319 ↗
• MalfunctionFeb 4, 2026Defective Alarm

  IT WAS REPORTED THAT THE VENT DID NOT ALARM WHEN DISCONNECTED FROM THE PATIENT. DURING INVESTIGATION FOUND THE EVENT OCCURRED DURING PATIENT USE AND THE EVENT HAD THE POTENTIAL TO INTERRUPT THERAPY. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258304 ↗
• MalfunctionJan 19, 2026Free or Unrestricted Flow

  THE CUSTOMER RETURNED THE DEVICE STATING, "THE DEVICE EXHIBIT LEAKAGE AT THE CIRCUIT CONNECTION POINT, HOWEVER THE ISSUE WAS NOT OBSERVED DURING USE". DURING DEVICE EVALUATION IT WAS FOUND THE DEVICE HAD CONTINUOUS FLOW ISSUE CAUSING OXYGEN/AIR TO PASS CONTINUOUSLY THROUGH PATIENT OUTLET CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111461 ↗
• MalfunctionDec 29, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE VENT WAS MISSING THE KNOB COVERS. THE FRONT PANEL WAS PANEL, AND IT WAS NOT VENTILATING¿; DURING DEVICE EVALUATION IT WAS FOUND THE DEVICE EXHIBITED CONTINUOUS FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918971 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD AN INTERNAL LEAK. THE EVENT OCCURRED DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910394 ↗
• MalfunctionDec 10, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PUMP DISPLAYED A PERSISTENT LOW-PRESSURE ALARM. A DIFFERENT PATIENT CIRCUIT WAS USED, BUT THE ALARM CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774932 ↗
• MalfunctionDec 8, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE DEVICE WAS NOT CYCLING PROPERLY AND JUST CONTINUOUSLY GIVING GAS FLOW. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750949 ↗
• MalfunctionDec 2, 2025Device Alarm System; Failure to Cycle; Device Alarm System; Failure to Cycle

  IT WAS REPORTED THAT THE UNIT DID NOT CYCLE BREATHS AND HAD ALARM ISSUES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696052 ↗
• MalfunctionNov 24, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PEEP SETTINGS WERE OFF, BELIEVED WAS OUT OF CALIBRATION. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638396 ↗
• MalfunctionNov 20, 2025Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE EXHIBITED LEAKAGE AND DID NOT DELIVER THE VOLUME. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606864 ↗
• MalfunctionNov 18, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE DEVICE WONT CYCLE OFF WHILE ON A PATIENT, JUST PROVIDES CONSTANT AIR FLOW, BIOMED WAS NOT ABLE TO DUPLICATE, ISSUE IS INTERMITTENT. THE DEVICE WAS NOT DROPPED AND THERE WAS NO DELAY OF THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584343 ↗
• MalfunctionOct 22, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A LOW-PRESSURE ALARM BEHAVIOR: INTERMITTENT ACTIVATION DURING NORMAL USE. ONCE ACTIVATED, IT WON¿T RESET UNLESS THE UNIT IS POWERED OFF/ON. FAILS FUNCTIONAL TEST AT STEP 9 ¿ ALARM TAKES OVER A MINUTE TO ACTIVATE INSTEAD OF 10 SECONDS. AFTER HIGH PRESSURE TEST (STEP 10 AND 11), BOTH HIGH- AND LOW-PRESSURE ALARMS FLASH, AND THE LOW-PRESSURE ALARM PERSISTS EVEN WHEN THE CONDITION IS CLEARED.2. HIGH PRESSURE RELIEF VALVE INACCURACY: SETPOINT: 40 CM H2O, BUT RELIEF OCCURS AT ~35 CM H2O. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357265 ↗
• MalfunctionOct 20, 2025Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337245 ↗
• MalfunctionOct 20, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE TIDAL KNOB WAS NOT WORKING. IT WOULD NOT VOLUME AND FLOW AT CORRECT AMOUNT. THE EVENT OCCURRED DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335644 ↗
• MalfunctionSep 9, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE DEVICE DOESN'T CYCLE, AND THE PRESSURE KEEPS GOING UP. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007298 ↗
• MalfunctionSep 9, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE USER OF THE DEVICE WAS UNABLE TO ADJUST THE SETTINGS, AND THE DEVICE WAS CONTINUOUSLY AT MAX OUTPUT WHEN CONNECTED TO AIR/OXYGEN. PER REPORTER, THE EVENT OCCURRED DURING SELF-TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004237 ↗
• MalfunctionSep 8, 2025Device Sensing Problem; Pressure Problem; Device Sensing Problem; Pressure Problem

  IT WAS REPORTED THAT THE VENT HIGH PRESSURE ALARMS CONTINUOUSLY. PER REPORTER, THIS EVENT OCCURRED WHILE IN USE WITH A PATIENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995999 ↗
• MalfunctionSep 3, 2025Material Puncture/Hole; High Test Results; Material Puncture/Hole; High Test Results

  IT WAS REPORTED THAT THE DEVICE FAILED OXYGEN CONCENTRATION AT 5.2.8 ON THE TEST SHEET, WAS SUPPOSED TO BE 44-46% AND THE ACTUAL TEST WAS 69.4 WHICH IS A LITTLE HIGHER. PER REPORTER, THE ISSUE OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960046 ↗
• MalfunctionAug 28, 2025No Flow; No Flow

  IT WAS REPORTED THAT THE DEVICE WAS NOT CYCLING. EVENT OCCURRED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912700 ↗
• MalfunctionAug 26, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE EQUIPMENT WAS NOT VENTILATING, AND NEEDLE MANOMETER WAS NOT MOVING. THE EVENT OCCURRED DURING PATIENT USE, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893242 ↗