Vital Signs IN900048Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817357020684), received between Mar 16, 2021 and Jul 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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.

• MalfunctionJul 17, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE STOPCOCKS ON THE BAGS OF INFUSOR, PRESSURE, 1000 ML, NETTED CONTINUOUSLY BREAK. THERE IS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334290 ↗
• MalfunctionMar 16, 2021Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ PRESSURE INFUSOR (500 ML) DO NOT HOLD PRESSURE/DEFLATED BUT CAN BE USED FOR INFUSIONS. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496450 ↗