Pneupac 150003Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical Pneupac is a facility ventilator, a machine that helps patients breathe. Its 79 reports, with no deaths and no injuries, all describe malfunctions, including alarms that did not sound, air or oxygen leaks, and pressure problems. Other reports describe a loose battery, missing knobs, and a unit that did not hold the set pressure level during testing. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10610586045578), received between Jun 27, 2018 and Apr 15, 2024 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (7 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.
Reports received per month
Most reported problems
Device problems
- Device Alarm System7
- Pressure Problem7
- Gas/Air Leak6
- Leak/Splash5
- Defective Component4
- Failure to Cycle4
- Calibration Problem3
- Defective Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information16
- No Patient Involvement14
- No Consequences Or Impact To Patient10
- No Information9
- No Known Impact Or Consequence To Patient7
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BATTERY DOOR AND BATTERY WERE LOOSE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19105755 ↗MalfunctionApr 9, 2024Gas Output Problem; Output Problem; Gas Output Problem; Output Problem
IT WAS REPORTED THAT THE UNIT WAS NOT GETTING CORRECT OUTPUT. THE ISSUE WAS FOUND DURING USE BUT THEY TOOK IT OFF AND DID NOT USE IT ON THE PATIENT. NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19071078 ↗MalfunctionMar 19, 2024Fracture; Defective Component; Component Missing; Battery Problem; Detachment of Device or Device Component; Fracture; Defective Component; Component Missing; Battery Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE BATTERY WELL AND TWO MISSING KNOBS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18935757 ↗MalfunctionMar 14, 2024Detachment of Device or Device Component; Improper Flow or Infusion; Detachment of Device or Device Component; Improper Flow or Infusion
IT WAS REPORTED THAT THE DEVICE WAS NOT HOLDING PEEP IN CMV PLUS PEEP. ISSUE WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18908769 ↗MalfunctionFeb 19, 2024Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible
IT WAS REPORTED THAT IT SOUNDS LIKE THERE IS AIR OR O2 LEAKING INSIDE THE UNIT. FOUND DURING TESTING AND THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18735723 ↗MalfunctionJan 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE UNIT WAS NOT WORKING PROPERLY. THE REPORTED PRODUCT FAULT OCCUR DURING TESTING. NO PATIENT INVOLVEMENT AND NO PATIENT ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432379 ↗MalfunctionSep 29, 2023No Audible Alarm; No Audible Alarm
IT WAS RECORDED THAT PM AND ALARM WILL NOT SOUND EVEN WITH NEW BATTERY. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17847789 ↗MalfunctionAug 1, 2023Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE REPORTER WOULD LIKE TO SEND THE DEVICE IN FOR PREVENTIVE MAINTENANCE AND FOR REPAIR FOR THE ALARM NOT GOING OFF WHEN DISCONNECTED. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17433077 ↗MalfunctionMay 8, 2023Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE UNIT IS NOT WORKING AS EXPECTED BY NOT HOLDING PEEP IN CMV AND PEEP. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 16891867 ↗MalfunctionMay 8, 2023Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION RECEIVED STATING "THERE WAS NO INCIDENT".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16890077 ↗MalfunctionApr 26, 2023Gas/Air Leak; Gas/Air Leak
ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THE CUSTOMER RESPONDED THE INFORMATION REQUESTED WAS NOT AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16820013 ↗MalfunctionApr 17, 2023Unable to Obtain Readings; Material Twisted/Bent; Unable to Obtain Readings; Material Twisted/Bent
IT WAS REPORTED THAT THE VENTILATOR O2 GAS SUPPLY INDICATOR WAS STICKY AND NOT WORKING PROPERLY AND THE CAP WAS BENT. NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 16752974 ↗MalfunctionApr 14, 2023Defective Component; Defective Component
IT WAS REPORTED THAT THE VENTILATOR DOWN STREAM OCCLUSION (DSO) SENSOR SEAL WAS BUBBLED. 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 16746927 ↗MalfunctionApr 14, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE VENTILATOR CONNECTOR WHERE THE CIRCUIT ATTACHES WAS BENT. 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 16745444 ↗MalfunctionApr 13, 2023Defective Device; Output Problem; Defective Device; Output Problem
ADDITIONAL INFORMATION RECEIVED: THE EVENT HAPPENED DURING TESTING ON (B)(6)2023. NO PATIENT HARM/INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16737284 ↗MalfunctionMar 23, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BATTERY DOOR HOLDER WAS FOUND DAMAGED DURING SETUP CHECK. THE UNIT RELEASE PRESSURE IS ALSO RELEASING SLOW. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16600323 ↗MalfunctionMar 14, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE VENTILATOR WAS NOT WORKING AND WAS NOT TURNING ON. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16542009 ↗MalfunctionFeb 24, 2023Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE CPAC WAS BEEPING FAILURE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16436603 ↗MalfunctionFeb 24, 2023Calibration Problem; Calibration Problem
IT WAS REPORTED THAT THE DEVICE FAILED THE PREVENTIVE MAINTENANCE. RELEASE VALVE PRESSURE ALARM CALIBRATION. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16435983 ↗MalfunctionDec 29, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THE DEVICE WAS NOT GIVING CORRECT O2. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16070262 ↗MalfunctionNov 21, 2022Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THERE WAS A DOUBLE PRESSURE ERROR. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15834031 ↗MalfunctionNov 18, 2022Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE UNIT HAS AN ISSUE GOING PAST TWENTY FOR THE PRESSURE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15827445 ↗MalfunctionNov 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE DEVICE MANOMETER WAS NOT READING WHAT IT WAS SET. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15793985 ↗MalfunctionNov 8, 2022Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT HOLD PEEP EVEN WHEN SET TO ZERO. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15754979 ↗MalfunctionNov 4, 2022Connection Problem; Connection Problem
ADDITIONAL INFO RECEIVED VIA EMAIL 8-NOV-2022. PER CUSTOMER, EQUIPMENT DOES NOT BELONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15726465 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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