Vital Signs IN800048Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10817357021063), received between Nov 25, 2020 and May 4, 2021 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionMay 4, 2021Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED THAT THE 500ML PRESSURE INFUSOR BAG MFG ITEM # IN800048 LOST PRESSURE MORE QUICKLY THAN NORMAL. THIS ISSUE OCCURRED WHILE CONNECTED TO A PATIENT AND THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771853 ↗
• InjuryMar 7, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS® PRESSURE INFUSOR HAS A LEAKING VALVE. IT HAPPENED DURING USE, AND THE MACHINE ALARMED "O2 CALIBRATION" AND "OCCLUSION." THE PATIENT HAD TO BE SEDATED FURTHER IN ORDER TO STOP THE ALARM FROM SOUNDING. HARM OR INJURY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426662 ↗
• InjuryNov 25, 2020Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS PRESSURE INFUSOR IS UNABLE TO MAINTAIN PUMP LEVEL. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER PRESSURE INFUSOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901167 ↗