Maxi Sky 2 MS115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05056097367934), received between Dec 23, 2022 and Aug 29, 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. 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 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOWING THE REPORTED INFORMATION, THE SPREADER BAR OF THE MAXI SKY 2 CEILING LIFT DETACHED FROM THE QUICK CONNECT MECHANISM AND HIT THE RESIDENT. IT OCCURRED WHEN THE FORCE WAS APPLIED TO POSITION THE RESIDENT. THE RESIDENT SUSTAINED SLIGHT BRUISING ON HEAD.THE DEVICE INSPECTION DID NOT REVEAL ANY FAILURE.

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093289 ↗
• MalfunctionDec 23, 2022Unintended Movement; Unintended Movement

  ARJO WAS INFORMED ABOUT THE INCIDENT INVOLVING THE MAXI SKY 2 CEILING LIFT. FOLLOWING THE INFORMATION PROVIDED, WHEN A PATIENT WAS BEING RE-POSITIONED USING A LIFT, THE DEVICE MADE ABNORMAL NOISES AND DROPPED THE PATIENT INTO BED SEVERAL INCHES. THE PATIENT DID NOT SUSTAIN ANY INJURY. AFTER THE EVENT AN ARJO REPRESENTATIVE VISITED THE CUSTOMER TO CONDUCT THE DEVICE INSPECTION. THE SERVICE TECHNICIAN INFORMED THAT THE MOST LIKELY CAUSE OF THE REPORTED INCIDENT WAS RELATED TO THE LIFT'S TRANSMISSION ASSEMBLY MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041229 ↗