Vital Signs™ 2016560-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752113558), received between Aug 22, 2022 and Aug 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CABLE, DCAR COMMUNICATION HOST CASE 15FT EXPERIENCED A BROKEN SOCKET ON CAM MODULE AND A BROKEN ACQUISITION CABLE PLUG DURING PATIENT USE. THE USER ATTENDING HEALTH PROFESSIONAL CANCELLED REST OF THE TEST NEEDED BY THE PATIENT. NO HARM IS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272399 ↗
• MalfunctionAug 22, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE CABLE, DCAR COMMUNICATION HOST CASE 15FT EKG ACQUISITION MODULE EXPERIENCED INTERMITTENT FAILURE DURING PATIENT STRESS TEST. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272390 ↗