MAUDE Adverse Event Report: STERIS SAS HEXALUX LIGHTING SYSTEM

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the lighting system and confirmed that the light's suspension arm had fully detached from the ceiling mount.The technician identified the root cause of the reported event to be the snap ring that secures the light's suspension arm to the ceiling mount.As the snap ring was not fully seated, over time, this allowed for the light's suspension arm to loosen and eventually detach from the ceiling mount resulting in the reported event.The unit was installed at the user facility in september 2018 and is currently under steris warranty.The lighting system was installed by a third-party service provider.The technician properly re-installed and secured the snap ring, tested the unit, and confirmed the lighting system to be operating according to specification.The technician performed an inspection of all the user facility's hexalux lighting systems and found them to be operating according to specification.Steris has re-trained the third-party service provider on proper installation of the hexalux lighting system.No additional issues have been reported.

Event Description

The user facility reported that their hexalux lighting system detached and fell to the floor while a patient was in the room.There were no injuries associated with the reported event.

• Brand Name: HEXALUX LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer (Section G): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8501024
• MDR Text Key: 142754800
• Report Number: 3011221111-2019-00002
• 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
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2019
• 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