Maxi Sky 440 LE00009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055982770521), received between Aug 6, 2024 and Aug 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Tipped Over” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 14, 2026Device Tipped Over

  Occupational Therapist and Project Lead for Assistive Devices (customer), informed an Arjo Equipment Consultant of the following event. On (B)(6) 2026, during an evening transfer from a wheelchair to the bed using an EasyTrack FS portable rail system (PRG-7409, purchased in 2023) and Maxi Sky 440 ceiling lift, the right support post collapsed, causing the rail to fall and strike the wall at the foot of the bed. As a result, the patient and the rail fell. No injury was reported.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251286 ↗
• MalfunctionAug 6, 2024Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION REPORTED THE STRAP UNWOUND UNEXPECTEDLY FULL LENGTH. THERE WAS NO INDICATION REGARDING PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED. THE FACILITY STAFF MANAGED TO RETRACT THE STRAP PARTIALLY BY PRESSING THE 'UP' BUTTON WITH SOME TENSION APPLIED, BUT AFTER THAT THE CEILING LIFT WAS UNRESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916498 ↗