MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 03/28/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony connectpoint and found that the friction brake was loose allowing the unit to drift down.The unit was installed in 2015 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 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 adjusted the friction brake, tested the unit, confirmed it to be operating to specification, and returned it to service.The technician counseled facility personnel on the proper 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 their harmony connectpoint drifted downward contacting an employee's head.The employee reported they experienced a headache following the reported event and medical treatment was sought.The user facility did not disclose if medical treatment was administered.The event did not occur during a patient procedure.

• 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: 11740588
• MDR Text Key: 250199681
• Report Number: 1043572-2021-00028
• 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: 04/28/2021

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: 03/29/2021
• Initial Date FDA Received: 04/28/2021
• 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