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

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

During patient set-up, an employee was bent over to examine something and as the employee raised up his head he contacted the corner of the lighting system's monitor.A steris service technician arrived onsite to inspect the harmonyair m series lighting system and was able to duplicate the drifting reported by the user facility.The harmonyair m series surgical lighting system operator manual states (pg.7-1), "problem- lighthead(s) or monitor arm(s) drifts once set in position and released.Brake friction, weighting or tension spring adjustment call your service representative, or if qualified consult section concerning suspension arm adjustments." the technician replaced and adjusted the tension on the lighting system brake screws and found the unit to be operational.No additional issues have been reported.

Event Description

The user facility reported that their lighting system was drifting and during patient set-up an employee's head inadvertently contacted the lighting system monitor resulting in a small cut.The employee did not seek medical treatment for the injury.No report of procedure delay or cancellation.The procedure was completed successfully.

• Brand Name: HARMONYAIR M SERIES 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: 7440984
• MDR Text Key: 106017300
• Report Number: 1043572-2018-00031
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• 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