HUDSON RCI IPN039351Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704662682), received between Feb 18, 2021 and Aug 2, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K964719); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 2, 2022Break; Break

  COMPLAINT REPORTED THAT: "DURING THE INSPECTION, THE NURSING AREA INDICATE THAT THE MASK WAS BROKEN". NO REPORT OF PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145664 ↗
• MalfunctionAug 2, 2022Break; Break

  COMPLAINT REPORTED THAT: "DURING THE INSPECTION, THE NURSING AREA INDICATE THAT THE MASK WAS BROKEN". NO REPORT OF PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145255 ↗
• MalfunctionAug 2, 2022Break; Break

  COMPLAINT REPORTED THAT: "DURING THE INSPECTION, THE NURSING AREA INDICATE THAT THE MASK WAS BROKEN". NO REPORT OF PATIENT HARM/INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15145222 ↗
• MalfunctionFeb 18, 2021Unintended Deflation; Unintended Deflation

  IT WAS REPORTED "THE RESPIRATORY DEPARTMENT IS HAVING COMPLAINTS THAT THE FACE CUSHION GOES FLAT AND THEY CAN NOT USE THEM". UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11344077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964719. One submission often covers many models, so check the product and lot details in each record.

• Z-1809-2015 · May 14, 2015 · Terminated
  Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medi