MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR A-SERIES CAMERA

Model Number	A-Series Camera
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the harmonyair a-series surgical lighting system and found that the in-light camera on the subject lighthead was not operating properly.The technician could not turn on/off the lighthead from the light handle or the wall controller.The technician also confirmed that a bank of led lights in the center of the subject lighthead were not illuminating.The technician disassembled the in-light camera subject of the reported event and observed wires caught in the gear assembly subsequently causing damage to the wire insulation.The steris service technician installed a new in-light camera, tested the function and operation of the harmonyair a-series surgical lighting system and confirmed the unit to be operating properly.The unit was returned to service and no additional issues have been reported.A complaint review was performed and confirmed this to be an isolated event.
Event or Problem Description
The user facility reported that during a patient procedure the in-light camera to one of the lightheads on their harmonyair a-series surgical lighting system was not operating properly.A section of the lighthead was also not illuminating.User facility personnel utilized the other lightheads and completed the patient procedure.A procedure delay occurred due to the reported event.No report of injury.

• Brand Name: HARMONYAIR A-SERIES CAMERA
• Common Device Name: HARMONYAIR A-SERIES CAMERA
• 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: 17362617
• Report Number: 1043572-2023-00126
• Device Sequence Number: 5289874
• Product Code: KQM
• UDI-Device Identifier: 00724995182427
• UDI-Public: 00724995182427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: A-Series Camera
• Device Catalogue Number: LAH0026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown