Pneupac 120002Recalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This ICU Medical Pneupac emergency ventilator is a powered resuscitator used in resuscitation. The 30 reports mostly describe equipment problems found during routine testing or maintenance: rattling noise inside the unit, cracked or broken knobs and keyboards, oxygen flowing when not expected, and units that would not build up or adjust pressure. There are no deaths, one injury, and 29 malfunctions. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10610586045479), received between Jun 4, 2018 and May 21, 2024 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Defective Device3
- Output Problem3
- Defective Component2
- Device Fell2
- Inaccurate Delivery2
- Noise, Audible2
- Output above Specifications2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information9
- No Information5
- No Known Impact Or Consequence To Patient4
- No Patient Involvement3
- Not Applicable1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Noise, Audible; Noise, Audible
IT WAS REPORTED THAT THE DEVICE HAS A RATTLING NOISE AND NEEDS A PM. THE ISSUE WAS NOT RELATED TO PHYSICAL DAMAGE/ABUSE OR DROPPED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360402 ↗MalfunctionApr 16, 2024Pressure Problem; Pressure Problem
IT WAS REPORTED THE DEVICE DOES NOT ADJUST OR BUILD UP PRESSURE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT. THE ISSUE WAS FOUND WHEN TESTING THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19120914 ↗MalfunctionMar 12, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT DURING TESTING, THE UNIT WAS NOT WORKING PROPERLY. NO PATIENT INVOLVEMENT. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888533 ↗MalfunctionDec 18, 2023Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED THAT THE UNIT HAD A BROKEN KNOB. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18352421 ↗MalfunctionOct 20, 2023Free or Unrestricted Flow; Device Difficult to Maintain; Free or Unrestricted Flow; Device Difficult to Maintain
IT WAS REPORTED THAT THE OXYGEN FREE FLOWS WHEN PLUGGED INTO OXYGEN. PREVENTATIVE MAINTENANCE (PM) NEEDED. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17971750 ↗MalfunctionOct 4, 2023Crack; Key or Button Unresponsive/not Working; Crack; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE DEVICE HAS A CRACKED KEYBOARD; IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR WHEN THE EVENT OCCURRED.
Patient problems: Insufficient Information
MAUDE report 17871163 ↗MalfunctionSep 11, 2023Tidal Volume Fluctuations; Tidal Volume Fluctuations
ADDITIONAL INFORMATION RECEIVED ON 07-OCT-2023 VIA EMAIL: EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17721525 ↗MalfunctionAug 24, 2023Noise, Audible; Noise, Audible
IT WAS REPORTED THAT THERE IS INTERNAL RATTLING. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17613655 ↗MalfunctionAug 7, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED VIA EMAIL. EVENT OCCURRED WHILE DEVICE WAS TAKEN TO THE EMERGENCY ROOM. EVENT DATE WAS UPDATED FROM UNKNOWN TO 01-MARCH-2023. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION,
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17471165 ↗MalfunctionJun 29, 2023Inaccurate Delivery; Defective Device; Inaccurate Delivery; Defective Device
IT WAS REPORTED THAT THE MANOMETER WAS INACCURATE AND AIR MIX FI O2>50%.PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17226857 ↗MalfunctionApr 21, 2023Break; Device Fell; Break; Device Fell
IT WAS REPORTED THAT THE VENTILATOR WAS DROPPED. FRONT DISPLAY IS "BLOWED OUT", KNOBS WERE MISSING AND RATTLING ON INSIDE. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16790812 ↗MalfunctionFeb 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE VALVES WERE STICKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16365392 ↗MalfunctionJan 18, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT FREE FLOWS FROM OUTLET PORT INTERMITTENTLY WHEN IT IS PLUGGED IN. DATE OF EVENT WAS UPDATED, THE ISSUE WAS FOUND DURING A ROUTINE CHECK, AND THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200221 ↗MalfunctionDec 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE DEVICE WAS NOT WORKING CORRECTLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000308 ↗MalfunctionSep 9, 2022Output above Specifications; Output above Specifications
IT WAS REPORTED THAT THE RELIEF PRESSURE VALVE AT 40 AND 60 SETTINGS IS RELIEVING TOO HIGH. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396728 ↗MalfunctionJul 12, 2022Defective Component; Pressure Problem; Defective Component; Pressure Problem
IT WAS REPORTED THAT THE VENTILATOR'S KNOBS WERE BROKEN AND THE DEVICE WAS NOT REACHING PRESSURE. NO PATIENT INJURY, ADVERSE AFFECTS, OR PATIENT INVOLVEMENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14986979 ↗MalfunctionJun 14, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE UNIT FAILED ON PATIENT PER CUSTOMER. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14686511 ↗MalfunctionApr 21, 2022Defective Alarm; Defective Alarm
IT WAS REPORTED THE DEVICE WAS NOT ALARMING. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14166304 ↗MalfunctionApr 13, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE IS SOMETHING LOSE ROLLING AROUND INSIDE. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14103060 ↗MalfunctionMay 10, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THE PNEUPAC VENTILATOR FAILED TO GIVE AN OXYGEN OUTPUT OF 100%. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11803186 ↗MalfunctionSep 20, 2020Failure to Cycle; Wireless Communication Problem; Failure to Cycle; Wireless Communication Problem
NO PATIENT INVOLVEMENT.
Patient problems: No Information; No Patient Involvement
MAUDE report 10558199 ↗MalfunctionSep 18, 2020Defective Component; Device Fell; Defective Component; Device Fell
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR WAS DROPPED CAUSING LIMITED ADJUSTMENT OF THE TIDAL VOLUME. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Information; No Patient Involvement
MAUDE report 10557225 ↗MalfunctionNov 20, 2019Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTILATORS PARAPAC HAS RATTLING INSIDE; LOOSE BODY INSIDE. NO PATIENT ADVERSE EFFECTS REPORTED.
Patient problems: No Information
MAUDE report 9347146 ↗MalfunctionOct 7, 2019Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTILATORS PARAPAC HAS RATTLING INSIDE; LOOSE BODY INSIDE. NO PATIENT ADVERSE EFFECTS REPORTED.
Patient problems: No Information
MAUDE report 9163752 ↗MalfunctionMar 29, 2019Output above Specifications; Calibration Problem; Output above Specifications; Calibration Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL VENTILATOR HAS A RESPIRATORY RATE THAT IS TOO HIGH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8466263 ↗
Other Ventilator, emergency, powered (resuscitator) devices
- Pneupac P310NUSIcu Medical, Inc. · Ventilator, emergency, powered (resuscitator)4 deaths1,035 reports
- Pneupac 120003Icu Medical, Inc. · Ventilator, emergency, powered (resuscitator)2 deaths523 reports
- Neo-Tee T-Piece Resuscitator 10-50805Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)3 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50811Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls3 reports
- Neo-Tee T-Piece Resuscitator 10-50809Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50810Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50832Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
- Neo-Tee T-Piece Resuscitator 10-50808Mercury Enterprises, Inc. · Ventilator, Emergency, Powered (Resuscitator)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.