MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY AIR G5 HD CAMERA READY PACK; SURGICAL LIGHTING SYSTEM

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

The lighting system was installed in (b)(6) 2016 and is not under a steris service contract for preventive maintenance.Maintenance activities are provided by the facility's biomed department.Immediately following the event, the facility's biomed department replaced the lighting system covers with inventory available in stock, tested the unit, and returned it to service.A steris service technician offered to inspect the lighting system and lighting covers following the event; however, the offer was declined.The customer stated that both pieces of the lighting system cover were damaged and had broken at the screw connecting point where the screw is installed to secure the covers to the lighting suspension arm.Based on the description of the event, it appears the detachment of the lighting system covers is attributed to impact damage from the lighting system contacting other equipment in the or environment.The harmony air g5 surgical lighting system operator manual includes a list of safety precautions which include: "caution - possible equipment damage: do not bump lightheads into walls or other equipment".Following the event, the facility's steris account manager counseled the facility on the importance of adhering to the safety precautions outlined in the unit's operator manual and provided the facility with an extra copy of the applicable warnings.No further issues have been reported.

Event Description

The user facility reported the lighting covers on their harmony air g5 surgical lighting system fell during patient procedure setup.The covers did not contact the patient or user facility staff.No injury, procedure delay, or cancellation occurred.

• Brand Name: HARMONY AIR G5 HD CAMERA READY PACK
• 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 ; 4403927453
• MDR Report Key: 7561014
• MDR Text Key: 109907343
• Report Number: 1043572-2018-00041
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 05/04/2018
• 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