Level 1 8002911Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50695085001872), received between Jul 17, 2019 and Mar 30, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• MalfunctionMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE H1200 FLUID WARMER EQUIPMENT, WAS IN SERVICE IN A 10 HOURS SURGERY, WHICH WAS SUPPOSED TO LAST FOR 20 HOURS TOTAL, BUT IT WAS INTERRUPTED, THE EQUIPMENT STARTED TO SEND AN ALARM, IT WAS OVERHEATING, IT DID NOT PERMIT TO RESTART THE PROCESS. THE EQUIPMENT PRESENTED A LEAKING AT THE RETURNING PIPE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950962 ↗
• MalfunctionJul 17, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL LEVEL 1 H-1200 FAST FLOW FLUID WARMER ES 115V PACKAGED WAS RECEIVED WITH DAMAGED PACKAGING. AIR SENSOR OUT OF ITS ORIGINAL POSITION. INTERMITTENT FAILURE IN SET DETECTION ALARM. DOES NOT RECOGNIZE THE SET. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8801073 ↗