SleepSafe Manual Hi-Lo ComboRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10860000213742), received between Sep 26, 2022 and Sep 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  RESUBMITTED (B)(6) 2022. (B)(6) [PT] ADVISED THAT DEXTER HAS BROKEN HIS WRIST WHILE IN A SLEEPSAFE BED. DEXTER'S GRANDFATHER ALLEGED THAT DEXTER HAD HIS HAND WEDGED BETWEEN THE MATTRESS AND THE PANEL AND SPECULATES THAT DEXTER TWISTED AND BROKE HIS WRIST. (B)(6) ADVISED THAT GRANDFATHER WAS TOLD BY THE NURSES THAT DEXTER WEDGES HIS HAND DOWN THERE "ALL THE TIME." ARRANGED FOR GRANDFATHER ((B)(6)) TO CALL SLEEPSAFE. GRANDFATHER ADVISES THAT HE WAS TOLD BY THE RN THAT THE NURSE PULLED DEXTER'S HAND OUT OF THE GAP AND DID NOT NOTICE ANY SIGNS OF INJURY AT THAT TIME. APPARENTLY NO ONE WITNESSED THE EVENT. GRANDFATHER ADVISES THAT DEXTER IS A COMPLEX CARE CHILD. GRANDFATHER FURTHER ADVISED THAT THERE IS AN OSTEO DIAGNOSIS AND THAT THIS MAY HAVE CONTRIBUTED TO SUSCEPTIBILITY TO THIS TYPE INJURY. WE CALLED THE DME (ALL ABOUT PEDIATRICS) REQUESTING THAT THE BED BE EVALUATED. DME INSPECTED AND ADVISED THAT THE ZONE 3 / 5 GAPS LOOK PROPER PER DESIGN.

  Patient problems: Limb Fracture

  MAUDE report 15487173 ↗