MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY AIR G SERIES SURGICAL LIGHTING SYSTEM

Device Problems Contamination (1120); Device Dislodged or Dislocated (2923); Device Fell (4014)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmonyair g series surgical lighting system.Prior to the technician's arrival, the cover had been re-installed by user facility personnel.While onsite, the technician found that the spring arm was not properly adjusted allowing the spring arm to make contact with the canopy cover.The reported event is attributed to impact damage resulting in the cover becoming dislodged.The unit was installed at the user facility in (b)(6) 2017 and is not under steris service agreement.The user facility is responsible for all maintenance activities.The technician adjusted the spring arm, tested the system, confirmed it to be operating according to specification, and returned it to service.The technician counseled facility personnel on the proper use and operation of the harmonyair g series surgical lighting system, specifically proper adjustment of the spring arm.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure the canopy cover on their harmonyair g series surgical lighting system had dislodged allowing dust to fall and enter the sterile field.The procedure was completed successfully.No report of injury.

• Brand Name: HARMONY AIR G 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 ; 4403927453
• MDR Report Key: 8962001
• MDR Text Key: 209025930
• Report Number: 1043572-2019-00074
• 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: 09/04/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/04/2019
• 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