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

Model Number E-Series

Device Problem Device Handling Problem (3265)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

A steris technician arrived onsite to inspect the lighting system and found that the touchscreen to their lighting system was sticky and had visible cleaning solution spots on it.The technician replaced the chassis assembly which includes the touchscreen, tested the lighting system, and found to be operating according to specifications.The lighting system was returned to service.The cleaning solution spots on the touchscreen observed by the technician is indicative of improper cleaning practices by user facility personnel subsequently causing the touchscreen to not work properly.The harmony air surgical lighting system e series operator manual states (section 6.1), "cleaning and disinfecting agents used on this lighting system must be certified by their manufacturer to be compatible with the following materials: polycarbonate (pc), thermoplastic elastomer (tpe), silicone, syndiotactic polystyrene (sps).Additionally, the harmony air surgical lighting system e series operator manual states (section 6.1), "do not spray any cleaning product directly onto the lighthead, touch panel control unit (tpcu) or any system components.Clean tpcu 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." while onsite, the technician counseled facility personnel on the importance of proper cleaning practices.No additional issues have been reported.

Event Description

The user facility reported that during patient procedures, the touchscreen to their harmony air surgical lighting system e series was not working properly.No report of injury or procedure delay.

• Brand Name: HARMONYAIR E-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: 14119068
• MDR Text Key: 289344225
• Report Number: 1043572-2022-00030
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995173746
• UDI-Public: 00724995173746
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E-Series
• Device Catalogue Number: LES01IN01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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