Pneupac 122003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586046063), received between Mar 14, 2017 and Mar 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT A PNEUPAC¿ PATIENT CIRCUIT WAS IN USE WITH A VENTILATED PATIENT ON A PORTABLE VENTILATOR WHEN IT WAS OBSERVED THAT THE CIRCUITRY TUBING AND THE PORTABLE VENTILATOR WERE CONNECTED INCORRECTLY. THE DEVICE ISSUE OCCURRED IN A HOSPITAL DURING A COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS NOTED THAT IT WAS UNCLEAR WHICH END OF THE TUBING SHOULD BE CONNECTED TO A GIVEN VALVE. THE DEVICE HAD TO BE DISCONNECTED, WHICH CAUSED THE PATIENT TO DECOMPENSATE DURING TRANSPORT. THE PATIENT BEGAN "'GASPING' FOR BREATHS" AND DEVELOPED BRADYCARDIA OF 30-40BPM. THE PATIENT WAS "MANUALLY [BAGGED]" AND ALSO PLACED ON A 100% FIO2 PORTABLE VENTILATOR AND RETURNED TO AN INTENSIVE CARE UNIT ROOM, WHERE THE PATIENT WAS RECONNECTED TO A VENTILATOR. NO PERMANENT INJURY WAS REPORTED. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Bradycardia; Hyperventilation

  MAUDE report 6403560 ↗