Maxi Sky 440 LE00000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055982795319), received between Sep 26, 2022 and Dec 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MAXI SKY 440 CEILING LIFT DETACHED AND FELL TOGETHER WITH THE PATIENT. NO INJURY WAS CLAIMED. THE MAXI SKY 440 PORTABLE CEILING LIFT MAY BE ATTACHED TO THE RAIL USING THE REACHER. THIS ACCESSORY IS COMPOSED OF THE REACHER ROD AND HOOK, CONNECTED TO EACH OTHER BY A MAGNET. TO CONNECT THE CEILING LIFT TO THE RAIL, THE REACHER'S HOOK NEEDS TO BE ATTACHED TO THE CEILING LIFT CARABINER AND CONNECTED TO THE RAIL TROLLEY. THE INSPECTION WAS PERFORMED BY ARJO TECHNICIAN IN PRESENCE OF DIRECTOR AND CAREGIVERS. IT REVEALED THAT THE REACHER'S HOOK WAS BENT. NO OTHER FAILURE WAS OBSERVED. THE LOAD TEST AT 200 KG WAS PERFORMED AND THE CEILING LIFT OPERATED CORRECTLY.

  Patient problems: Fall

  MAUDE report 20890936 ↗
• MalfunctionSep 26, 2022Device Tipped Over; Device Tipped Over

  ARJO WAS INFORMED ABOUT THE INCIDENT WITH THE MAXI SKY 440 CEILING LIFT AND EASYTRACK FS INSTALLATION SYSTEM INVOLVEMENT. IT WAS REPORTED THAT THE CUSTOMER¿S STAFF TRANSFERRED A PATIENT FROM A BED TO A POWERED WHEELCHAIR. AFTER COMPLETING THE TRANSFER, THE STAFF LEFT THE PATIENT IN THE ROOM. WHEN THE PATIENT WANTED TO LEAVE THE ROOM IN THE WHEELCHAIR, THE EASYTRACK FS FRAME PARTIALLY FELL FORWARD TWISTING TO THE LEFT. THE PATIENT MANAGED TO DRIVE UNDER THE FRAME AND LEFT THE ROOM. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THE REPORTED EVENT. AFTER THE INCIDENT, THE INSTALLATION WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. THE SERVICE TECHNICIAN OBSERVED THAT THE LIFT ATTACHED TO THE TRACK MOVED FROM ONE END TO ANOTHER DUE TO FRAME COLLAPSE AND THAT THERE WERE WHITE MARKS ON THE INSTALLATION TRACK WHICH CAME AWAY WHEN WIPED. THE TECHNICIAN PLACED THE INSTALLATION IN THE CORRECT POSITION AND PERFORMED A FUNCTION TEST. NO PROBLEM OCCURRED AFTER THE REPAIR AND THE SYSTEM WAS PUT BACK INTO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486582 ↗