Vital Signs IN800012Recalls & reported problems
Hygia Health Services, Inc. · Vital Signs Infusor, Pressure, 500cc · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817357021308), received between Jun 11, 2021 and Mar 10, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation 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
Device problems
- Inflation Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THE VITAL SIGNS® PRESSURE INFUSOR AIR OUTPUT IS DRAINING GRADUALLY. THE ISSUE OCCURRED DURING PATIENT-USE FOR 72 HOURS. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13722921 ↗MalfunctionJun 11, 2021Inflation Problem; Inflation Problem
THE CUSTOMER REPORTED THAT THE VITAL SIGNS® PRESSURE INFUSOR EXPERIENCED DEFECTIVE PRESSURE BAG. IT WILL NOT HOLD AIR WHEN INFLATED. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988202 ↗
Other Infusor, Pressure, For I.V. Bags devices
- Medex MX4705Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS36 reports
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 reports
- Medline DYNJAAPI1000SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS1 death9 reports
- Medline DYNJPI500CMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS7 reports
- Medline DYNJAAPI500SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS6 reports
- Vital Signs™ IN800012Airlife · INFUSOR, PRESSURE, FOR I.V. BAGS3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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