Pneupac 100/905/340-CHRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 15019517160215), received between May 5, 2020 and Dec 29, 2023 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT "SINGLE LIMB VENTILATOR CIRCUIT CONNECTED TO A VENTILATOR REQUIRING USE OF A TWO LIMBED VENTILATOR TUBING CIRCUIT. PACKAGING LACKED WARNING AND VENTILATOR ABLE TO DELIVER INSPIRATION BUT DID NOT ALLOW FOR EXHALATION. THE VENTILATOR MODEL USED WAS THE ZOLL EAGLE II WHICH REQUIRES THE 2-LIMB CIRCUITRY TUBING; HOWEVER, THE THERAPIST UTILIZED THE SINGLE LIMB CIRCUIT TUBING INTENDED FOR USE WITH THE PARAPAC TRANSPORT VENTILATOR. THERE WAS TEMPORARY HARM ¿ THE INSERTION OF A CHEST TUBE".

  Patient problems: Insufficient Information

  MAUDE report 18421018 ↗
• MalfunctionJul 12, 2023Crack; Crack

  DURING PRE-TEST, A CRACK NEAR THE BASE OF THE CIRCUIT WAS FOUND. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304587 ↗
• MalfunctionJul 7, 2023Failure to Deliver; Failure to Deliver

  UPON REVIEW 21-JULY-2023 THE AWARE DATE CHANGED FROM 10-JAN-2023 TO 27-JUNE-2023. THIS COMPLAINT WAS INITIATED AS A RESULT OF TESTING TO DOCUMENT A FURTHER COMPONENT INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 17283483 ↗
• MalfunctionMay 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEMISPHERICAL-SHAPED CAP OF EXHALATION VALVE EASILY COMES OFF DURING USE AND IT WAS LOST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883722 ↗
• MalfunctionMay 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A CRACK WAS FOUND IN THE CONNECTION PART. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869798 ↗
• MalfunctionMay 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE RELIEF PRESSURE VALUE DID NOT GO UP TO THE ASSIGNED ONE. IT WAS SUSPECTED THERE WAS LEAKAGE FROM THE AIR CIRCUIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861931 ↗
• MalfunctionJan 13, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER APPLIED A 20CMH2O OF AIR PRESSURE TO THE PRODUCT DURING THE PRE-USE CHECK, BUT IT FELL DOWN TO 13CMH2O. HE SUSPECTS THERE IS A HOLE OR LEAKAGE OF AIR IN THE PRODUCT. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157554 ↗
• MalfunctionNov 8, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT THE CUSTOMER MAXED OUT THE PEEP (POSITIVE END EXPIRATORY PRESSURE) SETTING, BUT THE ACTUAL VALUE REACHED 12-14 CMH2O. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754434 ↗
• MalfunctionSep 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, BEFORE OPENING THE PACKAGE, A HAIR-LIKE SUBSTANCE WAS FOUND IN IT; THE PRODUCT WAS NOT USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397889 ↗
• MalfunctionSep 10, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER FOUND A TEAR IN THE AIR HOSE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397753 ↗
• MalfunctionJun 2, 2022Failure to Sense; Unintended Movement; Failure to Sense; Unintended Movement

  IT WAS REPORTED THAT THE CUSTOMER CONNECTED THE PRODUCT TO AN P310 (A PARAPAC) DURING THE PRE-USE CHECK, BUT THE INDICATOR NEEDLE OF THE AIRWAY PRESSURE GAUGE DID NOT GO UP. SO THE CUSTOMER CHANGED THE PRODUCT TO ANOTHER ONE, AND THE INDICATOR NEEDLE ROSE. THUS HE SUSPECTS THERE IS AN ANOMALY IN THE PRODUCT. NO PATIENT INJURY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580928 ↗
• MalfunctionMar 3, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE CONNECTOR WAS FOUND DISCONNECTED. ALSO, A CAP WAS MISSING. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659519 ↗
• MalfunctionAug 29, 2021Pressure Problem; Pressure Problem

  INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC DISPOSABLE CIRCUITS MALFUNCTIONED. DURING A PRE-CHECK, WHEN THE CUSTOMER WAS CHECKING FOR OCCLUSION ALARM FROM THE PRODUCT (A PARAPAC PLUS), HE NOTICED THE INDICATOR OF THE AIRWAY PRESSURE METER DID NOT GO UP. SO HE ASKED (B)(6) TO CHECK AND REPAIR THE PRODUCT. THEN, (B)(6) CHECKED THE PRODUCT USING THE DEDICATED PNEUMATIC CIRCUIT AND FOUND THAT THE AIRWAY PRESSURE DID NOT RISE. NEXT, (B)(6) DID IT WITH (B)(6)'S OWN TESTING CIRCUIT AND THE PRODUCT WORKED WITHOUT PROBLEM. THE CUSTOMER REQUESTED US TO CHECK IF THERE IS ANY ANOMALY IN THE PRODUCT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381363 ↗
• MalfunctionJul 28, 2021Disconnection; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL VENTILATOR HAD AN EASILY DETACHED HEMISPHERICAL-SHAPED CAP FROM THE PATIENT-SIDE VALVE. THERE WAS NO PATIENT INJURY NEITHER REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240384 ↗
• MalfunctionJun 8, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL VENTILATOR HAD A VALVE COVER THAT WAS SO LOOSE IT WAS EASILY DETACHED. THE CUSTOMER REQUESTED THAT THE FIT OF THE COVER BE A LITTLE TIGHTER TO PREVENT IT FROM BEING DETACHED COMPLETELY. THERE WAS NO PATIENT INJURY. THIS ISSUE WAS NOTED DURING A PRE-USE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957518 ↗
• MalfunctionMar 16, 2021Pressure Problem; Pressure Problem

  DEVICE EVALUATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494953 ↗
• MalfunctionFeb 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND LEAKAGE OF AIR ON A SMITHS MEDICAL VENTILATOR. HE DID NOT USE IT. NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 11283667 ↗
• MalfunctionMay 5, 2020Increase in Pressure; Increase in Pressure

  INFORMATION WAS RECEIVED INDICATING THAT A HIGH-PRESSURE WARNING SOUNDED WHEN A SMITHS MEDICAL PNEUPAC¿ DISPOSABLE CIRCUIT WHEN CONNECTED TO A VENTILATOR. THE PRODUCT WAS CHANGED OUT AND THE VENTILATOR WORKED AS INTENDED. IT WAS REPORTED THAT THIS OCCURRED DURING PRE-USE TEST WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10025192 ↗