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

Device Problem Installation-Related Problem (2965)

Patient Problem Headache (1880)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure, the harmonyair m-series surgical lighting system fell from the ceiling and landed on the floor.It has been reported that a doctor received a head injury and medical treatment was sought out for a slight concussion.The procedure was completed successfully.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the lighting system had fallen from where the cover tube comes through the mounting plate.While onsite, the technician learned that the lighting system was purchased and installed through a third-party provider.The root cause of the reported event can be attributed to an installation error by the third party.The technician identified that there were no holes drilled for the safety ring and mounting pins on the cover tube above the ceiling structure resulting in the reported event.A copy of the installation instructions harmonyair surgical lighting system m series is shipped with every lighting system sold and includes the instructions to drill the holes for the safety ring and mounting pins.The installation instructions state (1-8), "caution - possible equipment damage: accurate measurement and calculation determining the point where the first hole should be drilled for the safety ring is of critical importance in correctly installing the vertical tube.Check all measurements and calculations twice before drilling the first hole." the instructions further state (1-7), "warning - personal injury hazard: the safety ring must be installed.Failure to install the safety ring and all four mounting pins could allow the harmonyair surgical lighting system m series suspension to fall during routine use." additionally, the installation instructions state (1-5), "caution - personal injury hazard and/or equipment damage hazard: repairs and adjustments to this equipment should be made only by fully qualified service personnel.Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty, or result in costly equipment damage.Contact steris regarding service options." a steris account manager provided in-service training to the user facility on proper installation activities, specifically utilizing fully qualified installation personnel.The technician installed a new lighting system at the user facility.No additional issues have been reported.

• Brand Name: HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM
• Type of Device: SURGICAL 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: 18528035
• MDR Text Key: 333545479
• Report Number: 1043572-2024-00005
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2015
• 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