Pneupac 122002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586046056), received between Dec 1, 2019 and Aug 21, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Loose or Intermittent Connection; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DURING TRANSPORT OF A CARDIAC PATIENT, THEY CONNECTED THE RESPIRATORY CIRCUIT TO THE ENDOTRACHEAL TUBE (ETT) AND NOTICED THE PATIENT WAS NOT RECEIVING ADEQUATE BREATHS. UPON INSPECTION, THEY FOUND THAT THE RUBBER BAND AROUND THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) ADAPTER WAS LOOSE AND OUT OF PLACE. THEY TESTED FOUR DIFFERENT CIRCUITS BEFORE IDENTIFYING ONE THAT FUNCTIONED PROPERLY AND ALLOWED THE PATIENT TO BREATH EFFECTIVELY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864536 ↗
• MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Loose or Intermittent Connection; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DURING TRANSPORT OF A CARDIAC PATIENT, THEY CONNECTED THE RESPIRATORY CIRCUIT TO THE ENDOTRACHEAL TUBE (ETT) AND NOTICED THE PATIENT WAS NOT RECEIVING ADEQUATE BREATHS. UPON INSPECTION, THEY FOUND THAT THE RUBBER BAND AROUND THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) ADAPTER WAS LOOSE AND OUT OF PLACE. THEY TESTED FOUR DIFFERENT CIRCUITS BEFORE IDENTIFYING ONE THAT FUNCTIONED PROPERLY AND ALLOWED THE PATIENT TO BREATH EFFECTIVELY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861459 ↗
• InjuryJan 5, 2021Insufficient Flow or Under Infusion; Improper Flow or Infusion; Insufficient Flow or Under Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT MRI TRANSPORT VENTILATOR CIRCUIT BECAME DISCONNECTED IN PACKAGE AND WAS REASSEMBLED INCORRECTLY AT THE TIME OF USE. WHEN INCORRECTLY ASSEMBLED, THE CIRCUIT WAS ATTACHED TO THE PATIENT CONNECTION AND THE PATIENT WAS CONNECTED WHERE THE CIRCUIT SHOULD BE, RESULTING IN BREATHS BEING DELIVERED OUT THE EXHALATION PORT. THE PATIENT REQUIRED BRIEF RESUSCITATION MEASURES. THE PATIENT RECOVERED WITHOUT FURTHER INCIDENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11119704 ↗
• InjuryDec 1, 2019Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON AN MRI VENTILATOR AND, THE VENTILATOR STARTED PEAK PRESSURING RIGHT AWAY. THE OPERATOR ATTEMPTED TO TROUBLESHOOT THE VENTILATOR BUT COULD NOT FIND THE SOURCE OF THE HIGH PRESSURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS RETURNED TO THE ROOM AND VENTILATED WITH AN AMU BAG. THE PATIENT WAS MONITORED USING A TRANSPORT MONITOR. INFORMATION PERTAINING TO THE CURRENT HEALTH STATUS OF THE PATIENT, OR IF THE ISSUE WAS ONGOING OR RESOLVED, WAS UNKNOWN.

  Patient problems: Hypoventilation

  MAUDE report 9392897 ↗