Mul-T-Blanket 8001-061-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327175127), received between Mar 12, 2019 and Nov 26, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Fluid/Blood Leak; Excessive Cooling; Fluid/Blood Leak; Excessive Cooling

  IT WAS ALLEGED THAT THE USER FACILITY HAS BEEN GETTING HOLES, THUS A "LEAK" IN THEIR BLANKET. THE WATER THEN SATURATES THE PATIENT AND THE BED, SPILLING ONTO THE FLOOR, THUS NOT ONLY NOT WARMING THE PATIENT, BUT COOLING THEM EVEN FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786571 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Excessive Cooling; Patient Device Interaction Problem; Fluid/Blood Leak; Excessive Cooling; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE ALTRIX BLANKET WAS LEAKING AND THAT THE PATIENT SUFFERED A SKIN INJURY.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 19811814 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Excessive Cooling; Patient Device Interaction Problem; Fluid/Blood Leak; Excessive Cooling; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REPLACEMENT BLANKET THAT WAS POSITIONED UNDER THE PATIENT SHOWED SIGNIFICANT WATER IMBIBITION WITH FROST. IT WAS REPORTED THAT THERE IS SEEPAGE AT THE LEVEL OF THE BLANKET TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Discoloration

  MAUDE report 19811425 ↗
• MalfunctionJul 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN ATTEMPTING TO USE ON A PATIENT AND PRE-FILLING WITH WATER, THE BLANKET EXPERIENCED LEAKING IN THE MIDDLE. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724890 ↗
• MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HOOKED THE PATIENT UP TO THE COOLING BLANKET AND THE BLANKET WAS NOTICED TO HAVE HOLES. THE HOLES WERE NOTICED IMMEDIATELY AFTER HOOKING UP TO THE MACHINE, BECAUSE WATER STARTED SPRAYING OUT OF HOLES IN THE MIDDLE OF THE BLANKET. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616698 ↗
• MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HOOKED THE PATIENT UP TO THE COOLING BLANKET AND THE BLANKET WAS NOTICED TO HAVE HOLES. THE HOLES WERE NOTICED IMMEDIATELY AFTER HOOKING UP TO THE MACHINE, BECAUSE WATER STARTED SPRAYING OUT OF HOLES IN THE MIDDLE OF THE BLANKET. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616697 ↗
• MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HOOKED THE PATIENT UP TO THE COOLING BLANKET AND THE BLANKET WAS NOTICED TO HAVE HOLES. THE HOLES WERE NOTICED IMMEDIATELY AFTER HOOKING UP TO THE MACHINE, BECAUSE WATER STARTED SPRAYING OUT OF HOLES IN THE MIDDLE OF THE BLANKET. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616693 ↗
• MalfunctionAug 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NEW ALTRIX BLANKET WAS APPLIED TO A PATIENT AND IT WAS LEAKING WATER FROM A SMALL HOLE. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436379 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE ALTRIX MACHINE WAS RUNNING, THE ALTRIX BLANKET BURST WITH WATER WHILE ATTACHED TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A PREEXISTING GRADE 3 PRESSURE SORE WITH A NEWLY DRESSED WOUND. DUE TO BURSTING OF THE BLANKET, THE DRESSING BECAME SOILED AND THE WOUND WAS WET. THE PROCEDURE WAS NOT COMPLETED AND THE WOUND NEEDED TO BE REDRESSED USING AN ASEPTIC TECHNIQUE. NO INJURY WAS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898792 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ALTRIX BLANKET BEGAN TO LEAK ONTO THE PATIENT WHILE IN USE, CAUSING THE PATIENT'S TEMPERATURE TO DROP TO 35C. THE USER FACILITY REPORTED THAT THERE WAS A 3-5 MINUTE DELAY IN TREATMENT AS THEY REPLACED THE GROUNDING PAD BUT CONFIRMED THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Alteration in Body Temperature

  MAUDE report 12469473 ↗
• MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT THE BLANKET STARTED LEAKING BEYOND THE CONNECTION. IT WAS FURTHER REPORTED THAT WATER WAS RUNNING DOWN THE CLEAR TUBING FROM THE BLANKET ITSELF INDICATING THERE MAY BE A HOLE IN THE BLANKET. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728909 ↗
• MalfunctionOct 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PREPARING FOR A CASE THE BLANKET POPPED AND LEAKED WATER ON TO THE PATIENT SUPPORT AREA. THERE WAS NO PATIENT INVOLVED AT THE TIME OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10658059 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUFFERED SOME SKIN DAMAGE AND / OR BLISTERS WHILE USING A TEMPERATURE THERAPY BLANKET THE CUSTOMER DESCRIBED THE DEVICE THAT WAS BEING USED WITH THE BLANKET AS A MEDITHERM, HOWEVER THEY COULD NOT VERIFY THIS AS THEY DID NOT PROVIDE A SERIAL NUMBER.

  Patient problems: Swelling; Tissue Damage

  MAUDE report 8414331 ↗