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 08/15/2023

Event Type  malfunction  

Event Description

The user facility reported that paint on multiple ligtheads to their harmonyair a-series surgical lighting systems are chipping and peeling.Patient procedures were subsequently cancelled.No report of injury.

Manufacturer Narrative

A steris account manager stated there are three operating rooms with harmonyair a-series surgical lighting systems which have lightheads with paint chipping and peeling.The three lighting systems subject of the reported event are: 0403923125, 0403923121 and 0403923129.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 counseled user facility personnel on the importance of following proper cleaning procedures for their lightheads.The steris service technician replaced all subject lightheads, tested the function and operation of the units and returned them to service.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: 17746992
• MDR Text Key: 323802735
• Report Number: 1043572-2023-00137
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995186562
• UDI-Public: 00724995186562
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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