Vital Signs™ 1552016 (UDI 10190752118188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752118188), received between Jul 12, 2024 and Jan 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE CIRCUIT BROKE WHILE BEING USED ON A PATIENT. PATIENT STABLE BUT 5 MINUTE DELAY IN TREATMENT AS A NEW CIRCUIT WAS OBTAINED AND RECONNECTED.

  Patient problems: Respiratory Arrest

  MAUDE report 24104151 ↗
• MalfunctionNov 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT CIRCUIT WOULD NOT STAY ON MACHINE HAS BEEN GOING ON FOR THE LAST TWO WEEKS WITH OTHER CASES. THE FILTER ON EACH LIMB IS DISCONNECTING WHICH IS NOT ALLOWING THE CIRCUIT TO STAY ON THE MACHINE. PATIENT WENT INTO CODE BLUE CASE WAS CONTINUED.

  Patient problems: Respiratory Arrest

  MAUDE report 23501761 ↗
• MalfunctionApr 4, 2025Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT TWO DIFERENT DEVICES DURING USE THE ETCO2 PIGTAIL COMES OFF THE HME. TWO SEPARATE REPORTS WILL BE SUBMITTED THE SECOND REPORT NUMBER IS 8030673-2025-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21780703 ↗
• MalfunctionJul 12, 2024Disconnection; Connection Problem; Disconnection; Connection Problem

  THE CONNECTIONS AT THE BLUE AND WHITE TUBBING SEPARATED VERY EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732000 ↗