Pneupac 130003Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10610586038259), received between Mar 8, 2018 and Aug 21, 2024 — classified as 1 death, 2 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (18 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 77 reports, in the reporter's own words as published by the FDA.

• DeathAug 21, 2024No Audible Alarm; Failure to Cycle; No Audible Alarm; Failure to Cycle

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL INFORMING THAT A 69-YEAR-OLD MALE WHO SUFFERED A MOTORCYCLE ACCIDENT RESULTING IN SUBARACHNOID HEMORRHAGE AND MULTIPLE CRITICAL INJURIES. PATIENT WAS FOUND TO HAVE ANOXIC BRAIN INJURY, WAS PLACED ON COMFORT MEASURES AND PASSED AWAY. MRI BEING COMPLETED AT TIME OF EVENT ON (B)(6) 2024 AND THE FAMILY OF PATIENT REQUESTING RESULTS OF INVESTIGATION AND EQUIPMENT MALFUNCTION FINDINGS. THE EVENT OCCURED IN RADIOLOGY. DATE OF DEATH WAS NOT PROVIDED.

  Patient problems: Respiratory Arrest

  MAUDE report 20010876 ↗
• InjuryJun 25, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE FAILED TO ALARM. THE PATIENT WAS INTUBATED AND MECHANICALLY VENTILATED. PATIENT COMPLETED MRI WITH INSTANCES OF OVERBREATHING AND ASYNCHRONY NOTED. PATIENT WAS TRANSFERRED FROM MRI BED TO ICU BED IN MRI WAITING AREA WHEN OXYGEN DESATURATION EVENT TO 70S OCCURRED. THE DEVICE WAS ATTACHED TO MRI OXYGEN SUPPLY AND FUNCTIONING WITH FIO2 50%. OXYGEN SATURATION DID NOT IMPROVE AND FIO2 INCREASED TO 100% WITH THE DEVICE STILL FUNCTIONING. OXYGEN SATURATION DID NOT IMPROVE. PATIENT WAS REMOVED FROM THE DEVICE AND MANUALLY BAGGED UNTIL OXYGEN SATURATION IMPROVED TO 100%. PATIENT WAS PLACED BACK ON THE DEVICE AND "LOW SUPPLY CHARGE" LIGHT BEGAN FLASHING WITH NO DISCERNABLE FUNCTION. PATIENT WAS MANUALLY BAGGED BY RN WHILE THE DEVICE WAS BEING CHECKED. OXYGEN CONNECTIONS TIGHT AND CIRCUIT APPROPRIATELY CONNECTED. PATIENT MAINTAINED OXYGEN SATURATIONS DURING TRANSPORT BACK TO ROOM. THE DEVICE CONNECTED TO WALL O2 IN ICU AND CHECKED FOR FUNCTION. " LOW SUPPLY CHARGE" LIGHT FLASHING AND NO DETECTABLE FUNCTION OBSERVED. THERE WAS DELAY OF TREATMENT. HARM REPORTED WAS LOW O2 SAT FOR UNSPECIFIED TIME. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM NOT SIGNIFICANT REP

  Patient problems: Hyperventilation; Low Oxygen Saturation

  MAUDE report 19610753 ↗
• MalfunctionJun 4, 2024Device Alarm System; Break; Device Alarm System; Break

  IT WAS REPORTED THAT IT HAS BROKEN CASE WHERE THE BATTERY CAP IS AND IT'S NOT MAKING CONTACT AND THE ALARMS ARE NOT WORKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19462623 ↗
• MalfunctionJun 4, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THERE WAS A RATTLING NOISE INSIDE THE UNIT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459420 ↗
• MalfunctionFeb 12, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING ANNUAL PREVENTATIVE MAINTENANCE (PM), THE ALARMS WERE NOT WORKING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18688051 ↗
• MalfunctionJan 30, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT CIRCUIT CONNECTOR WAS TOO LOOSE AND WOULDN'T WORK CORRECTLY, CAUSING INTERNAL LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610466 ↗
• MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE UNIT HAD MISSING ADJUSTMENT KNOBS AND WAS IN NEED OF CALIBRATION. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18162692 ↗
• MalfunctionNov 6, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE DEVICE WAS ONLY HOLDING BATTERIES FOR A FEW HOURS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077327 ↗
• MalfunctionSep 27, 2023Loose or Intermittent Connection; Gas/Air Leak; Loose or Intermittent Connection; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAS A LOOSE PIECE AND AIR LEAKING. THE FAULT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829918 ↗
• MalfunctionAug 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE HAD A BROKEN CASE AND BATTERY COVER. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17650294 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT THE BATTERY CASE WAS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565215 ↗
• MalfunctionAug 4, 2023Break; Battery Problem; Break; Battery Problem

  IT WAS REPORTED THAT THE BATTERY COVER WAS DAMAGED. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17464225 ↗
• MalfunctionJun 30, 2023Device Alarm System; No Audible Alarm; Alarm Not Visible; Break; Device Alarm System; No Audible Alarm; Alarm Not Visible; Break

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239938 ↗
• MalfunctionMay 8, 2023Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT THE VENTILATOR FAILED PREVENTIVE MAINTENANCE STEP 4 OF THE FUNCTIONAL TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890252 ↗
• MalfunctionMay 4, 2023Imprecision; Detachment of Device or Device Component; Imprecision; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GAUGE WAS NOT WORKING AND SOMETHING WAS LOOSE INSIDE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16869803 ↗
• MalfunctionApr 28, 2023Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837269 ↗
• MalfunctionMar 29, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE HIGH PRESSURE ALARM WAS NOT WORKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633240 ↗
• MalfunctionMar 28, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE GAUGE HOUSING WAS CRACKED AND GAUGE WAS AT AN ANGLE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 6-OCT-21: EVENT DATE WAS (B)(6) 2021, FOUND IN ATTEMPT TO PERFORM PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633162 ↗
• MalfunctionMar 3, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATOR FAILED TO REACH THE INSPIRATORY PRESSURE REQUIRED. ADDITIONALLY, THE DEVICE ALSO HAS A CIRCUIT LEAK AND IS DUE FOR SERVICING. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16482765 ↗
• MalfunctionJan 5, 2023Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  IT WAS REPORTED THE GAUGE OF THE DEVICE IS NOT WORKING AND NOT DETECTING BREATHS ALL THE TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108872 ↗
• MalfunctionOct 20, 2022Device Alarm System; Battery Problem; Device Alarm System; Battery Problem

  IT WAS REPORTED THAT THE BATTERY ALARM IS NOT WORKING PROPERLY. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642414 ↗
• MalfunctionOct 14, 2022Low Readings; Low Readings

  IT WAS REPORTED THAT THE DEVICE OXYGEN LEVEL WAS BELOW SETTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606037 ↗
• MalfunctionOct 14, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE TURNS OFF WHILE IN USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605938 ↗
• MalfunctionSep 20, 2022Defective Alarm; Defective Alarm

  ADDITIONAL INFO RECEIVED VIA EMAIL 27-SEP-2022: EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455904 ↗
• MalfunctionSep 12, 2022Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT THE DEVICE IS NOT BOOTING UP CONSISTENTLY. BATTERY COMPARTMENT NOT ALWAYS MAKING CONTACT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401347 ↗