BIRD SENTRY2 30623-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846446065053), received between Oct 26, 2020 and Oct 26, 2020 — classified as 1 malfunction.

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

• MalfunctionOct 26, 2020Crack; Protective Measures Problem

  CAREFUSION BIRD SENTRY 2 HIGH FLOW AIR/OXYGEN BLENDERS HAVE BEEN EXPERIENCING LARGE CASE CRACKING IN BOTH THE FRONT AND BACK ASSEMBLIES. THESE DEVICES ARE ONLY 12-18 MONTHS OLD. THE CRACKS ARE AFFECTING THE OPERATION OF THE DEVICE. THE BUTTONS ARE NOT ABLE TO BE REACHED OR LOSE FUNCTION, AND IT PRESENTS AN INFECTION CONTROL RISK FOR FLUID INGRESS AND BACTERIA GROWTH. MANUFACTURER RESPONSE FOR HIGH FLOW AIR/OXYGEN BLENDER, BIRD SENTRY 2 (PER SITE REPORTER). THERE IS NO WARRANTY COVERAGE FOR THESE DEVICES. PAYMENT REQUIRED FOR REPAIR WORK ((B)(6) PER DEVICE).

  Patient problems: Insufficient Information

  MAUDE report 10733109 ↗