Rapr-Round 8001-061-540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327175073), received between Jun 6, 2019 and Jun 3, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE BLANKET WAS LEAKING WHILE IN USE ON A PATIENT. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11933815 ↗
• MalfunctionDec 8, 2020Filling Problem; Device Displays Incorrect Message

  ELDERLY FEMALE WITH HISTORY OF MULTIPLE SCLEROSIS AND RECENT CARDIAC WORKUP. WHEN APPLYING THE STRYKER LEG WARMER. THE MACHINE ALARMED "CHECK WATER FLOW". ALL CLAMPS CHECKED ON TUBING AND MACHINE- ALL CLAMPS WERE OPEN AND LEG WRAP WOULD STILL NOT FILL WITH WATER. LEG WRAP WAS SWITCHED, AND ERROR CORRECTED, ALLOWING WATER TO FLOW INTO PAD AND WORK PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 10966906 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED THAT A PATIENT DEVELOPED NON-BLANCHABLE AREAS AT THE BOTTOM OF THEIR LEGS. IT WAS STATED THAT THE PATIENT WAS SEEN BY WOUND CARE BUT NOT TREATED AND THE FAMILY WITHDREW CARE AND THE PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT WAS POST CARDIAC ARREST AND ON THE TARGETED TEMPERATURE MANAGEMENT PROTOCOL. THE EVENT WAS NOT REPORTED TO HAVE CAUSED THE PATIENT DEATH.

  Patient problems: Death; Tissue Damage

  MAUDE report 8675278 ↗
• InjuryJun 6, 2019Patient-Device Incompatibility

  IT WAS ALLEGED THAT A PATIENT WAS USING THE WRAP AND DEVELOPED BLISTERS ON THEIR LEG. THE CUSTOMER ALLEGES THAT THE PATIENT REQUIRED WOUND CARE CONSULT AND WAS TREATED. IT WAS REPORTED THAT THE PATIENT WAS POST CARDIAC ARREST AND ON THE TARGETED TEMPERATURE MANAGEMENT PROTOCOL.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 8675275 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED THAT A PATIENT DEVELOPED BLISTERS ON THEIR BACK. THE CUSTOMER ALLEGES THAT THE PATIENT REQUIRED WOUND CARE CONSULT AND WAS TREATED. IT WAS REPORTED THAT THE PATIENT WAS POST CARDIAC ARREST AND ON THE TARGETED TEMPERATURE MANAGEMENT PROTOCOL.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 8675272 ↗