MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony connectpoint and found the friction brake was loose allowing the arm to drift and the reported event to occur.The unit was installed in 2011 making it approximately 9 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.The reported event is attributed to improper preventive maintenance activities by user facility personnel, specifically not regularly inspecting and adjusting the friction brake.The harmony connectpoint operator manual (11-1) states: "start at the highest point on the suspension, and work out toward the lightheads on each suspension arm.Verify proper operation of each braking point.If necessary, adjust each of the brakes in turn, with the goal of eliminating both binding and drift in the system." the technician tightened the brake, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on proper preventive maintenance activities, specifically inspecting and adjusting the brakes in accordance with the operator manual.No additional issues have been reported.

Event Description

The user facility reported that while an operator was moving their harmony connectpoint, the arm drifted making contact with an employee's head.Medical treatment was sought and the employee received time off of work.

• Brand Name: HARMONY CONNECTPOINT
• Type of Device: HARMONY CONNECTPOINT
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9642337
• MDR Text Key: 208977747
• Report Number: 1043572-2020-00007
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1