Immerse Mattress Family Immerse FamilyRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845699004393), received between May 30, 2025 and Jun 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL FROM BED AND SUSTAINED AN ACUTE FRACTURE OF THE RIGHT SUPERIOR PUBIC RAMUS.

  Patient problems: Bone Fracture(s)

  MAUDE report 25487351 ↗
• MalfunctionMay 30, 2025Overheating of Device; Overheating of Device

  PATIENT PRESENTED WITH BREAKDOWN ON BUTTOCKS UPON ADMISSION AND WITH TREATMENT AND THE IMMERSE SUPPORT SURFACE THE SKIN WAS HEALING. AFTER SEVERAL DAYS OF BEING ON THE SURFACE, STAFF REQUESTED PATIENT BE MOVED TO REGULAR ICU SURFACE AS THE "SURFACE UNIT WAS BECOMING VERY HOT". PATIENT'S BACK REGION WAS BECOMING MORE REDDENED, AND SHE HAD A SPIKED TEMP AS WELL. WHEN THEY MOVED HER TO A REGULAR ICU SURFACE, THEY REPORTED PATIENT'S TEMP WENT DOWN 2 DEGREES. TWO DAYS AFTER BEING PLACED ON REGULAR ICU SURFACE, PATIENT'S BUTTOCKS APPEARED VERY DARK AND PURPLE IN DISCOLORATION.

  Patient problems: Erythema

  MAUDE report 22116624 ↗