Pneupac 520A1300USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586045738), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K051322); they may or may not involve this specific model.

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

• MalfunctionSep 12, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE PNEUPAC VENTILATORS VR1 AIR MIX FAILED TO STAY IN AUTO MODE. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7870904 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051322. One submission often covers many models, so check the product and lot details in each record.

• Z-0991-2007 · May 16, 2007 · Terminated
  Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by