Mon-a-Therm 90056Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30884521077595), received between Sep 19, 2018 and May 13, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Connection 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, LIQUID WAS LEAKING FROM THE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401093 ↗
• MalfunctionNov 5, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE DEVICE GAVE READINGS OF 36 DEGREES CELSIUS DURING OPERATION. HOWEVER, BASED ON THE OBSERVATION OF THE PATIENT BY AN EXPERIENCED PROFESSION AND PATIENT HAVING INCREASED HEART RATE, PATIENT¿S TEMPERATURE WAS MEASURED AGAIN IN THE EAR AND GAVE 38 DEGREE CELSIUS WHICH SHOWED DEVIATION OF 2 DEGREES CELSIUS DOWNWARDS COMPARE TO THE DEVICE. THE PATIENT WAS SICK WITH COVID, AN ECMO WAS RUNNING AND ABOUT 14 DAYS AGO THE PATIENT DIED AS A RESULT OF COVID AND THERE WAS NO RELATION TO THE DEVICE.

  Patient problems: Death

  MAUDE report 10791888 ↗
• MalfunctionAug 3, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD BALLOON THAT DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355830 ↗
• InjurySep 19, 2018Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS NOT CONTINUOUS, NO URINE COULD RUN THROUGH THE TUBE. IT WAS INDICATED THAT THE PATIENT WAS IN SEPTIC SHOCK, THERE WAS NO URINE MONITORING POSSIBLE. THE CATHETER WAS CHECKED, AND IT COULD NOT BE RINSED OR ASPIRATED. IT WAS ALSO REPORTED THAT THE OVERALL CONDITION OF THE PATIENT COULD HAVE BEEN WORSENED DUE TO ABNORMAL DISCHARGE, POSSIBLY THAT THE URINE GOES BACK TO THE KIDNEYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7888955 ↗