MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY DUAL LED585 LIGHTING SYSTEM

Device Problem Unintended Movement (3026)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

The user facility reported that their harmony dual led585 light drifted during a patient procedure contacting the doctor's head.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the light and found that the brakes to the lighting system were loose causing the light head to drift slowly.Additionally, the brakes found on the main spindle were worn and required replacement.The technician replaced the main spindle brakes.The unit was tested, confirmed to be operating according to specifications and returned to service.The steris account manager offered in-service training, but the customer declined stating they would make their biomed personnel aware of the necessary preventive maintenance.The harmony led585 lighting system operator manual states (pg 22) "if the lighthead does not remain in position, tighten the brakes to the articulations in order to increase the friction".Figure 6-3 (pg 28) states "use a 2.5 mm hexagonal allen wrench to increase the braking force, rotating the arm brake screws clockwise".The lighting system was manufactured in 2012 making it approximately 11 years old.The harmony sual led585 lighting system is not under steris service agreement for maintenance.The user facility is responsible for all maintenance activities.No additional issues have been reported.

• Brand Name: HARMONY DUAL LED585 LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• 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
• MDR Report Key: 18061198
• MDR Text Key: 327258598
• Report Number: 1043572-2023-00157
• 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: 11/02/2023

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: 10/06/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2012
• 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