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

Device Problem Flaked (1246)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

The user facility reported that paint on multiple light heads to their harmonyair a-series surgical lighting systems are chipping and peeling.No report of injury.

Manufacturer Narrative

The six lighting systems subject of the reported event are: 0403321038, 0406921044, orapar13072970191, orapar13072970199, 0406421079, and 0407421028.A steris service technician arrived onsite to inspect the harmonyair a-series surgical lighting systems and found that paint was chipping and peeling on multiple lightheads.The technician cleaned the lightheads and applied touch-up paint to the lighting systems.The technician tested the lighting systems and confirmed them to be operational.The lighting systems were returned to service.The reported paint chipping and peeling is attributed to improper cleaning practices by user facility personnel, specifically not properly drying the equipment after cleaning.The operator manual states (8.1), "operator manual maintenance 8.1 cleaning equipment warning-personal injury hazard: do not attempt to clean lighthead unless power is turned off and the lighthead has cooled sufficiently.Caution-possible equipment damage: use of any disinfectant solution other than those listed here may cause discoloration or deformation on the lens surface and other system components:."."the use of h2o2 + paa (hydrogen peroxide + peracetic acid) is strongly discouraged for use on all steris products.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 offered in-service training to user facility personnel on the importance of following proper cleaning procedures for their lightheads however, the user facility has not yet responded.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

A steris account manager offered in-service training to user facility personnel on the importance of following proper cleaning procedures for their lightheads however, the user facility declined.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
• MDR Report Key: 18488835
• MDR Text Key: 333098300
• Report Number: 1043572-2024-00002
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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
• Date Manufacturer Received: 12/12/2023
• 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