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

Device Problem Device Fell (4014)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician and the user facility's biomed department inspected the lighting system and did not observe any particulates falling during their inspection.During the inspection, the technician observed paint chipping on the suspension components which is indicative of impact damage as well as residual white material, dried blood, and dust on the lighting system.The technician replaced the suspension arm due to the observed paint chipping, tested the light system, confirmed it to be operating according to specification, and returned it to service.The harmonyair m series surgical lighting system operator manual states (1-3), "caution - possible equipment damage: do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the operator manual further states (6-4), "the following areas of the lighting system must be cleaned and disinfected before each use of the system: lighthead and monitor suspension arms, lighthead, lighthandle" the account manager offered in-service training on the proper use, operation, and cleaning of the harmonyair m series surgical lighting system; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported that particulate matter fell from the connectpoint arm of their harmonyair m series surgical lighting system during a patient procedure entering the sterile field.The procedure was postponed.No report of injury.

• Brand Name: HARMONYAIR M SERIES SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9771404
• MDR Text Key: 208967692
• Report Number: 1043572-2020-00013
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• 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