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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY HARMONY AIR G SERIES SURGICAL LIGHTING SYSTEM Back to Search Results
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.

 
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Brand NameHARMONY AIR G SERIES SURGICAL LIGHTING SYSTEM
Type of DeviceSURGICAL 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 Key8962001
MDR Text Key209025930
Report Number1043572-2019-00074
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
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

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