MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED385 EXAMINATION LIGHTING SYSTEM

Device Problem Installation-Related Problem (2965)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

The user facility reported that their harmony led385 examination lighting system detached from the ceiling.No patients or employees were in the room at the time of the event.No injuries or procedure delays were reported.

Manufacturer Narrative

A steris surgical service representative inspected the lighting system and found that it was not installed properly.Steris did not install the harmony led385 examination lighting system subject of the reported event.The lighting system was installed by the user facility's subcontractor in (b)(6) 2013.The steris surgical service representative found that the tube suspension had not been drilled properly by the subcontractor at the time of installation allowing the screw and its washer to not engage into the ceiling plate.The harmony led385 examination lighting system subject of the reported event was repaired and re-installed by the user facility's engineering department.Steris requested access to the equipment to ensure the lighting system was repaired and installed properly however, the user facility declined steris access to the room.The steris surgical service representative proactively inspected all other harmony led385 examination lighting systems and found that they were not installed correctly per steris equipment maintenance requirements.A steris service technician was able to make repairs and adjustments to the user facility's other harmony led385 surgical lighting systems.The light systems were tested and confirmed to be operating according to specifications.The steris equipment maintenance requirements harmony led 385 light preventative maintenance check list (764327-327) rev.2 12/23/13 step 5.0 final testing/admin - perform at each maintenance inspection.Sub-section 5.1 - check for proper installation.For ceiling mount units, remove canopy and check for tightness of mounting screws and that the vertical tube and plate are secure.Steris discontinued the harmony led385 examination lighting system in (b)(6) 2017.No additional issues have been reported.

• Brand Name: HARMONY LED385 EXAMINATION 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 ; 4403927453
• MDR Report Key: 14732898
• MDR Text Key: 302260938
• Report Number: 1043572-2022-00044
• Device Sequence Number: 1
• Product Code: KZF
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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