PneupacRecalls & reported problems across all models

We found 23 models of Pneupac by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,972 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2017 and Sep 29, 2026 — classified as 7 deaths, 36 injuries, 1,929 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (239 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Pneupac problems

Pneupac models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pneupac P310NUS

  Ventilator, emergency, powered (resuscitator)
  4 deaths1,035 reports
• Pneupac 120003

  Ventilator, emergency, powered (resuscitator)
  2 deaths523 reports
• Pneupac 150003

  VENTILATOR, CONTINUOUS, FACILITY USE
  79 reports
• Pneupac 130003

  Ventilator, emergency, powered (resuscitator)
  1 death77 reports
• Pneupac 530A1167

  Ventilator, emergency, powered (resuscitator)
  74 reports
• Pneupac P300NUS

  Ventilator, emergency, powered (resuscitator)
  44 reports
• Pneupac 120002

  Ventilator, emergency, powered (resuscitator)
  30 reports
• Pneupac P200DNUS

  Ventilator, emergency, powered (resuscitator)
  27 reports
• Pneupac 520A1299US

  Ventilator, emergency, powered (resuscitator)
  20 reports
• Pneupac 100/905/340-CH

  Attachment, breathing, positive end expiratory pressure
  18 reports
• Pneupac V200DNUS

  Ventilator, emergency, powered (resuscitator)
  17 reports
• Pneupac 510A1960NONEU

  Ventilator, emergency, powered (resuscitator)
  6 reports
• Pneupac 122002

  Ventilator, emergency, powered (resuscitator)
  4 reports
• Pneupac 100/905/300-CH

  Ventilator, emergency, powered (resuscitator)
  4 reports
• Pneupac 100/905/340

  Attachment, breathing, positive end expiratory pressure
  3 reports
• Pneupac VR1AIRNUS

  Ventilator, emergency, powered (resuscitator)
  3 reports
• Pneupac 130002V

  Ventilator, emergency, powered (resuscitator)
  2 reports
• Pneupac 130002

  Ventilator, emergency, powered (resuscitator)
  1 report
• Pneupac 520A1300US

  Ventilator, emergency, powered (resuscitator)
  1 report
• Pneupac 122003

  Ventilator, emergency, powered (resuscitator)
  1 report
• Pneupac 100/905/360

  Attachment, breathing, positive end expiratory pressure
  1 report
• Pneupac 100/905/361

  Attachment, breathing, positive end expiratory pressure
  1 report
• Pneupac 100/905/320-CH

  Ventilator, emergency, powered (resuscitator)
  1 report

Recent Pneupac adverse event reports

The 15 most recent reports across all models, 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 18, 2026Break; Failure to Cycle

  IT WAS REPORTED THAT THE VENTILATOR WAS NOT CYCLING BREATHS AND THE RELIEF ALARM PRESSURE KNOB WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626729 ↗
• 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 24, 2026Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE HAD TRIGGERED A LOW-PRESSURE ALARM, AND DESPITE TRYING DIFFERENT TUBING, THE SAME ALARM HAD CONTINUED. IT WAS ALSO REPORTED THAT THE FRONT PANEL HAD A CRACK AND THE BATTERY DOOR HAD ALSO SUSTAINED CRACKS. THE EVENT HAD OCCURRED DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433821 ↗
• MalfunctionFeb 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS INTERNAL GAS LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271287 ↗
• 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 ↗

Other Icu Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Medex98 models · 774 reports · 23 recalls
• Plum26 models · 1,358 reports · 6 recalls