MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXI SKY 1000; LIFT, PATIENT, NON-AC-POWERED

Model Number MAXY SKY 1000

Device Problems Self-Activation or Keying (1557); Malposition of Device (2616); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

Several medical centers are reporting issues with arjo maxi sky 1000 overhead lifts.Our two primary concerns involve the maximum weight capacity and the emergency stop function.One of the most significant findings thus far is that downward drift occurs after the activation of the emergency stop mechanism when using the lifts within the advertised safe working load limit of 1,000 pounds.This issue has been confirmed by facility testing, a third-party assessor, and acknowledged by the manufacturer as a non-ideal performance characteristic of their product.Results from several medical centers exhibited downward drift (12 inch drop to the floor under the safe working load) occurring at rates of 8, 12, 17, 18, 60, and 60+ seconds after engaging the emergency stop.

• Brand Name: MAXI SKY 1000
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; dennis genito; 45 barbour pond dr.; wayne NJ 07470
• MDR Report Key: 6102859
• MDR Text Key: 60046004
• Report Number: 6102859
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAXY SKY 1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1