MAUDE Adverse Event Report: STERIS CORPORATION HARMONY IQ 2800 INTEGRATION SYSTEM

Model Number	Harmony iQ 2800
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure that the surgical light to their harmony iq 2800 integration system turned off then on without being commanded.The lights were immediately manually turned back on with the surgical wall control, and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the system and was unable to duplicate the reported event.The technician reset the power distribution board, tested the system, confirmed it to be operating according to specification, and returned it to service.The investigation for the reported event is still in process; a follow-up mdr will be filed when additional information becomes available.
Additional Manufacturer Narrative
The user facility notified the steris service technician that a facility water leak occurred in the ceiling of the or prior to the reported event due to a burst water pipe.Due to the water leak, the technician performed an additional service visit to ensure there was no additional damage to the equipment and no visual damage observed.The water leak may have caused or contributed to the reported event; however, the technician was unable to confirm.While onsite, the technician replaced the spindle commutators and reset the integration system.The technician tested the integration system and lighting system, confirmed them to be operating to specification, and returned them to service.No additional issues have been reported.

• Brand Name: HARMONY IQ 2800 INTEGRATION SYSTEM
• Common Device Name: INTEGRATION SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 503 canal blvd.; richmond CA 94804
• Manufacturer (Section G): STERIS CORPORATION; 503 canal blvd.; richmond CA 94804
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16522786
• Report Number: 3008776287-2023-00001
• Device Sequence Number: 12390762
• Product Code: FTA
• UDI-Device Identifier: 00724995199135
• UDI-Public: 00724995199135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: Harmony iQ 2800
• Device Catalogue Number: RLQ2000SLC
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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