MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT

Device Problem Unintended Collision (1429)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and learned from user facility personnel that the harmony connectpoint was being held up with an iv pole as the brakes were loose.At the time of the reported event, an employee bumped into the iv pole allowing the harmony connectpoint to drift resulting in the reported event.The technician inspected the harmony connectpoint and confirmed that the brakes were loose.The unit was installed in 2017 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 activites by user facility personnel, specifically not regularly inspecting and adjusting the friction brake.The harmony connectpoint operator manual states (11-1), "the friction brakes may require adjustment over time.If the harmony connectpoint should drift when released during articulation, use the following procedure to adjust brake tension and reduce drift." the technician replaced the brake assembly, tested the unit, confirmed it to be operating to specification, and returned it to service.A steris account manager performed in-service training on the proper preventive maintenance of the harmony connectpoint, specifically regularly inspecting and adjusting the friction brake as needed.No additional issues have been reported.

Event Description

The user facility reported that at the end of a procedure during patient transfer their harmony connectpoint drifted making contact with the patient's head.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: 11246010
• MDR Text Key: 243730857
• Report Number: 1043572-2021-00005
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/28/2021
• 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