Flowmeter, CM 31970Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813830021141), received between Apr 24, 2025 and Aug 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. BELIEVES SEDATION LEVELS ARE HIGHER THAN UNIT SHOWS. THIS UNIT WAS PREVIOUSLY REPAIRED AND RETURNED BUT DR. COMPLAINED THAT UNIT IS MAKING PATIENTS SICK.

  Patient problems: Nausea

  MAUDE report 22882511 ↗
• InjuryJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORT OF PATIENT GETTING SICK.

  Patient problems: Dizziness

  MAUDE report 22344897 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT 3 PATIENTS GOT SICK - INSTANTLY, DURING AND END OF PROCEDURES. ONE PATIENT FAINTED. NO EMERGENCY SERVICES WERE CALLED AND NO PATIENTS VOMITED.

  Patient problems: Dizziness

  MAUDE report 21901013 ↗