MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM

Model Number A-Series Lighting System

Device Problem Flaked (1246)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The user facility reported that paint on multiple lightheads to their dual harmony surgical lighting systems is bubbling and chipping.No report of injury.

Manufacturer Narrative

A steris account manager stated there are five or rooms with dual harmony surgical lighting systems which have lightheads with paint bubbling and chipping (10 total lightheads).The five lighting systems subject of the reported event are: (b)(4).The steris account manager confirmed the customer is using an approved cleaning solution however, user facility personnel are directly spraying the cleaning product onto the light heads instead of applying the cleaning product onto a cloth and then cleaning the lighthead.The operator manual states (section 8), "always follow manufacturer instructions for concentrations and use of cleaning products.Do not spray any cleaning product directly onto the lighthead, integrated wall control (iwc) or any system components.Clean iwc screen with a clean, lint-free cloth dampened with 90% isopropyl alcohol.For other system components, dampen a clean, soft cloth with the cleaning solution and wring out the excess moisture." the steris account manager in-serviced user facility personnel on the proper cleaning practices for their dual harmony surgical lighting systems.All 10 lightheads subject of the reported event have been replaced.No additional issues have been reported.

• Brand Name: HARMONYAIR A-SERIES SURGICAL 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: 15635650
• MDR Text Key: 307162233
• Report Number: 1043572-2022-00067
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995188467
• UDI-Public: 00724995188467
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-Series Lighting System
• Device Catalogue Number: LAS01IN01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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