Vital Signs™ IN800012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752133723), received between Nov 10, 2022 and Sep 26, 2023 — classified as 3 malfunctions.

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

• MalfunctionSep 26, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE IN800012 INFUSOR, PRESSURE, 500 ML, NETTED, 12/C LOSES INFLATION PRESSURE,CAUSING BLOOD BACKFLOW AND CLOGGING OF THE TUBING. THE ISSUE HAPPENED DURING PATIENT USE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822545 ↗
• MalfunctionJul 9, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS BAG IS UNABLE TO PRESSURIZE. PATIENT INVOLVEMENT IS NOT CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17284078 ↗
• MalfunctionNov 10, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS HAS AN AIR LEAKAGE DURING PATIENT'S SURGERY. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774367 ↗