Pneupac 120003Recalls & reported problems

Summary

The FDA's MAUDE database contains 523 adverse event reports that list this exact device (DI 10610586045486), received between Dec 20, 2017 and Jul 11, 2025 — classified as 2 deaths, 7 injuries, 514 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (87 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 523 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025No Audible Alarm; No Flow; No Audible Alarm; No Flow

  IT WAS STATED THAT DEVICE STOPPED WORKING AND IT HAD NO ALARM - 45 SECONDS STARTED WORKING AGAIN THEN IT STOPPED RANDOMLY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS DELAY OF THERAPY. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484955 ↗
• MalfunctionSep 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT¿S OXYGEN SATURATION DROPPED WHEN PLACED ON PARAPAC. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278303 ↗
• MalfunctionAug 22, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ALARM FUNCTIONS WERE NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025575 ↗
• MalfunctionAug 7, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PRE-CHECKOUT THE MRI VENT HAS A LOUD LEAK WHEN TURNED ON, WHICH SOUNDED INTERNAL. ALL EXTERNAL CONNECTIONS WERE CHECKED AND WERE TIGHT. A RUSH OF AIR WAS FELT FROM THE FRONT DIAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934475 ↗
• MalfunctionJun 19, 2024Material Puncture/Hole; Component Missing; Material Puncture/Hole; Component Missing

  IT WAS REPORTED THAT TWO OF THE KNOBS WERE MISSING AND THERE WAS A HOLE IN THE MIDDLE OF THE UNIT. THE ISSUE WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566571 ↗
• MalfunctionJun 4, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE HAS MISSING BATTERY COVER AND THERE WERE SOME HAIR LINE CRACKS FOUND DURING VISUAL INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459612 ↗
• MalfunctionJun 4, 2024Fracture; Battery Problem; Fracture; Battery Problem

  IT WAS REPORTED THAT THE DEVICE HAS A CRACK ON THE BACK AND BATTERY NEEDS A REPLACEMENT. THIS WAS DISCOVERED DURING VISUAL INSPECTION OF PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459373 ↗
• MalfunctionMay 16, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ALARM AND ALERTS WERE NOT FUNCTIONING. THE WAS ISSUE FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331182 ↗
• MalfunctionMay 13, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TRANSPORTATION OF THE DEVICE PRIOR TO USE IT WAS DROPPED AND THE FRONT PANEL AND KNOBS ARE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298193 ↗
• MalfunctionApr 29, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. IT WAS UNKNOWN IF THE DEVICE WAS DROPPED OR NOT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202163 ↗
• MalfunctionApr 29, 2024Defective Alarm; Break; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation; Defective Alarm; Break; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation

  IT WAS REPORTED THAT THE FREQUENCY KNOB WAS INTERMITTENT AND HIGH-PRESSURE READINGS WERE LOW WHEN HEIGHT WAS TURNED UP. ADDITIONALLY, THE SUPPLY GAS FAILURE ALARM WAS DEFECTIVE WITH BROKEN PLASTIC THAT MOVED THE RED AND WHITE O2 BALL INSIDE, AND A NEW GAS UNIT WAS NEEDED. THERE WAS NO ISSUE RELATED TO PHYSICAL DAMAGE/ABUSE. THE UNIT WAS NOT DROPPED AT ALL. THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202154 ↗
• MalfunctionApr 25, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE WAS GIVING A CONSTANT LOW PRESSURE ALARM. THERE WAS NO ISSUE RELATED TO PHYSICAL DAMAGE/ABUSE. THE UNIT WAS NOT DROPPED AT ALL. THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183404 ↗
• MalfunctionApr 25, 2024Crack; Crack

  IT WAS REPORTED THAT THE DEVICE HAS A CRACKED LOWER LEFT OF THE GAUGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182467 ↗
• MalfunctionApr 22, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE DEVICE ALARM DOES NOT WORK. CUSTOMER TRIED TO REPLACE BATTERY AND STILL DOES NOT WORK.. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19155008 ↗
• MalfunctionApr 22, 2024Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE DEVICE HAD AN ISSUE WITH THE VENT PROVIDING CONSTANT OPEN PRESSURE. IT DID NOT ALWAYS CYCLE EVERY BREATH. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152978 ↗
• MalfunctionApr 16, 2024Failure to Cycle; Failure to Deliver; Failure to Cycle; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE DID NOT DELIVER OXYGEN. THERE WAS NO PHYSICAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116066 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT THE VENT HAD A BROKEN AIR MIX KNOB. THE PRODUCT FAULT OCCURRED DURING EITHER SELF-TESTING OR DURING THE BEGINNING OF THE SHIFT AND WAS RELATED TO PHYSICAL DAMAGE/ABUSE OR THE UNIT WAS DROPPED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116055 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED FACE PLATE AND KNOBS. THE NURSE REPORTED DESATURATION ON PATIENT. THE DELAY OF THERAPY WAS UNKNOWN AND ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19112177 ↗
• MalfunctionApr 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE THE LED WAS NOT TURNING ON. LIGHTS ARE NOT ILLUMINATING WHEN THE DEVICE IS TURNED ON. THE PRODUCT FAULT OCCURRED DURING TESTING AT THE BIOMED SHOP. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045878 ↗
• MalfunctionMar 26, 2024Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing

  IT WAS REPORTED THAT THE DEVICE TRANSPORT VENT HAD MISSING KNOBS OR RELIEF/ALARMS PRESSURE AND AIR MIX FUNCTIONS. PHYSICAL DAMAGE TO THE FRONT LEFT WHERE THE KNOBS WOULD GO WAS PUSHED IN FURTHER THAN IT SHOULD BE, MAKING THE KNOBS HARD TO TURN. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981259 ↗
• MalfunctionMar 26, 2024Defective Component; Pressure Problem; Defective Component; Pressure Problem

  IT WAS REPORTED THAT THE PRESSURE METER IS DEFECTIVE. THE PRODUCT FAULT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980970 ↗
• MalfunctionMar 25, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE DEVICE WAS MISSING A KNOB AND PREVENTIVE MAINTENANCE WAS NEEDED. THEY VERIFIED WITH THEIR BIOMED TECHNICAL: "OUTSIDE OF THE MISSING KNOB WITH CAP THERE IS NO OTHER PHYSICAL DAMAGE TO SUGGEST IT WAS DROPPED". NO PATIENT INVOLVEMENT REPORTED WITH THIS INCIDENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975319 ↗
• MalfunctionMar 25, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DEVICE HAS PHYSICAL DAMAGE SURROUNDING WHERE THE MRI BATTERY WAS INSTALLED. "PROBABLY NEEDS A PREVENTIVE MAINTENANCE AND BATTERY." THE PRODUCT FAULT OCCURRED BEFORE USE OR DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973859 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE HAD PHYSICAL DAMAGE AROUND THE BATTERY AREA WHERE PARTS OF THE CASING WERE MISSING AND BROKEN-OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973807 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS STATED THAT THE DEVICE HAS A BROKEN FACE PLATE. PATIENT INVOLVEMENT IS UNKNOWN. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973124 ↗