Pneupac 530A1167Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 35019315107478), received between Oct 8, 2018 and Feb 5, 2026 — classified as 8 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 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 74 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 31, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER CONNECTING TO THE GAS, A CONTINUOUS FLOW WAS DETECTED, EVEN WHEN THE DEVICE WAS SWITCHED OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049333 ↗
• MalfunctionDec 30, 2024Failure to Calibrate; Failure to Calibrate

  A DEVICE WAS RETURNED FOR INVESTIGATION WITH NO REPORTED REASON FOR THE RETURN. UPON INVESTIGATION, A FAULTY DEMAND VALVE AND VRV WAS FOUND. NO PATIENT HARM OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037063 ↗
• MalfunctionDec 12, 2024Loose or Intermittent Connection; Unintended Movement; Loose or Intermittent Connection; Unintended Movement

  IT WAS REPORTED THAT THERE WAS A RISK OF UNINTENTIONAL MOVEMENT OF THE TIDAL VOLUME KNOB FROM ITS ORIGINAL SETTING, PARTICULARLY WHEN SET TO HIGH (1000 ¿ 1500 ML) OR LOW (70 ¿ 150 ML) VALUES. THERE WAS A RISK THAT THE PATIENT OUTLET CONNECTOR COULD LOOSEN OR DETACH FROM THE PARAPAC PLUS¿ P300 AND P310 VENTILATORS, AFFECTING THE ACTIVE VENTILATION FUNCTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914641 ↗
• MalfunctionDec 12, 2024Loose or Intermittent Connection; Unintended Movement; Loose or Intermittent Connection; Unintended Movement

  IT WAS REPORTED THAT THERE WAS A RISK OF UNINTENTIONAL MOVEMENT OF THE TIDAL VOLUME KNOB FROM ITS ORIGINAL SETTING, PARTICULARLY WHEN SET TO HIGH (1000 ¿ 1500 ML) OR LOW (70 ¿ 150 ML) VALUES. THERE WAS A RISK THAT THE PATIENT OUTLET CONNECTOR COULD LOOSEN OR DETACH FROM THE PARAPAC PLUS¿ P300 AND P310 VENTILATORS, AFFECTING THE ACTIVE VENTILATION FUNCTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914624 ↗
• MalfunctionDec 12, 2024Loose or Intermittent Connection; Unintended Movement; Loose or Intermittent Connection; Unintended Movement

  IT WAS REPORTED THAT THERE WAS A RISK OF UNINTENTIONAL MOVEMENT OF THE TIDAL VOLUME KNOB FROM ITS ORIGINAL SETTING, PARTICULARLY WHEN SET TO HIGH (1000 ¿ 1500 ML) OR LOW (70 ¿ 150 ML) VALUES. THERE WAS A RISK THAT THE PATIENT OUTLET CONNECTOR COULD LOOSEN OR DETACH FROM THE PARAPAC PLUS¿ P300 AND P310 VENTILATORS, AFFECTING THE ACTIVE VENTILATION FUNCTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914201 ↗
• MalfunctionNov 18, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED, THAT THE PRODUCT WAS GIVING HIGH PRESSURE ALARM. THERE WAS NO PATIENT INVOLVEMENT. AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705728 ↗
• MalfunctionAug 22, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE WAS A BROKEN PRESSURE GAUGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030740 ↗
• MalfunctionAug 21, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE "BULLET" THAT SHOWS IF THERE IS INCOMING OXYGEN PRESSURE DOES NOT ALWAYS WORK. IT STOPS HALFWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013983 ↗
• MalfunctionAug 5, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD A HIGH PRESSURE ALARM. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906794 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak; Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD INACCURATE READINGS, A DEFECTIVE MANOMETER, INTERNAL LEAKAGE, AND A DEPLETED BATTERY. THE PRODUCT IS AVAILABLE FOR REPAIR. THIS WAS DISCOVERED PRIOR TO PATIENT USE AND THERE WAS NO PATIENT HARM. THE REPORTED PRODUCT FAULT OCCURRED DURING TESTING AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840391 ↗
• MalfunctionJul 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKING OCCURRED INSIDE THE VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840377 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak; Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD INACCURATE READINGS, A DEFECTIVE MANOMETER, INTERNAL LEAKAGE, AND A DEPLETED BATTERY. THE PRODUCT IS AVAILABLE FOR REPAIR. THIS WAS DISCOVERED PRIOR TO PATIENT USE AND THERE WAS NO PATIENT HARM. THE REPORTED PRODUCT FAULT OCCURRED DURING TESTING AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840050 ↗
• MalfunctionJul 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN OXYGEN LEAKAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840044 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak; Incorrect, Inadequate or Imprecise Result or Readings; Defective Component; Battery Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD INACCURATE READINGS, A DEFECTIVE MANOMETER, INTERNAL LEAKAGE, AND A DEPLETED BATTERY. THE PRODUCT IS AVAILABLE FOR REPAIR. THIS WAS DISCOVERED PRIOR TO PATIENT USE AND THERE WAS NO PATIENT HARM. THE REPORTED PRODUCT FAULT OCCURRED DURING TESTING AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839575 ↗
• MalfunctionJun 24, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE EXPIRATORY VALVE WAS MISSING. THE DEVICE WAS OUT OF WARRANTY, AND THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601154 ↗
• MalfunctionJun 21, 2024Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT THE DEVICE HAS BEEN SENT FOR PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586267 ↗
• MalfunctionJun 11, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE HAD A DEFECTIVE OXYGEN INDICATOR. THE EVENT OCCURRED DURING QUALITY CONTROL. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511419 ↗
• MalfunctionMay 16, 2024Defective Device; Battery Problem; Defective Device; Battery Problem

  IT WAS REPORTED THAT THE DEVICE HAS FAILED, WOULDN'T VENTILATE, FLASHING LOW BATTERY AND CANNOT GET IT TO WORK. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332388 ↗
• MalfunctionMay 7, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE OPERATORS REPORTED AN OXYGEN LEAK FOR THIS DEVICE. THE REPORTER CHECKED THE DEVICE AND THERE APPEARS TO BE NO LEAK EXTERNALLY AND THE DEVICE OPERATES AS IT SHOULD. HOWEVER, WHEN THE OXYGEN HOSE IS CONNECTED TO THE OXYGEN TANK AND THE SWITCH IS SET TO "OFF", THERE IS A HISSING NOISE COMING FROM INSIDE THE DEVICE. MICHAEL CARRICK FROM BARTS HEALTH NHS TRUST, REPORTED ON BEHALF OF THE ROYAL LONDON HOSPITAL. THEY ARE UNSURE OF THE EVENT'S DATE. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION. THE ISSUE WAS FOUND BEFORE USE WITH A PRE USE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264972 ↗
• MalfunctionApr 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICE HAD PHYSICAL DAMAGE AND NEEDED REPAIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19165264 ↗
• MalfunctionApr 9, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PRESSURE NEEDLE WAS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19072570 ↗
• MalfunctionMar 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE OXYGEN WELL IS NOT WORKING. THE EVENT OCCURRED AT (B)(6) HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE DEVICE WILL NOT BE RETURNING TO ICU MEDICAL FOR REPAIR. THIS PRODUCT WILL BE REPAIRED EITHER AT HELMIER SERVICE CENTER OR WOULD BE REPAIRED IN THE FIELD IN INDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888353 ↗
• MalfunctionMar 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD A LEAKAGE ISSUE. THE EVENT OCCURRED AT (B)(6) HOSPITALS. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE PRODUCT WILL NOT BE RETURNING TO ICU MEDICAL FOR REPAIR. THIS PRODUCT WILL BE REPAIRED EITHER AT HELMIER SERVICE CENTER OR WOULD BE REPAIRED IN THE FIELD IN INDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888305 ↗
• MalfunctionMar 12, 2024Mechanical Problem; Key or Button Unresponsive/not Working; Mechanical Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT "THE REGULATOR KNOB WORKING, PEEP NOT WORKING, AND THE O2 INDICATOR IS NOT WORKING". THE EVENT OCCURRED AT S D LIFECARE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM ADVERSE EVENT REPORTED. THE PRODUCT WILL NOT BE RETURNING TO ICU MEDICAL FOR REPAIR. THIS PRODUCT WILL BE REPAIRED EITHER AT HELMIER SERVICE CENTER OR WOULD BE REPAIRED IN THE FIELD IN INDIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888300 ↗