MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony connectpoint and was able to duplicate the reported drift.The reported event is attributed to the friction brake being loose allowing the arm to drift and the reported event to occur.This is caused by improper preventive maintenance activities, specifically not regularly inspecting and adjusting the friction brake.The unit was installed in 2014 making it approximately 7 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.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." in lieu of repairs per request by user facility personnel, the technician deinstalled the harmony connectpoint as it was not being used.No additional issues have been reported.

Event Description

The user facility reported that their harmony connectpoint arm drifted and contacted an employee's head.The event did not occur during a patient procedure.No report of injury.

• 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: 11315093
• MDR Text Key: 243758964
• Report Number: 1043572-2021-00008
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• 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