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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR E-SERIES SURGICAL LIGHTING SYSTEM

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STERIS CORPORATION - MONTGOMERY HARMONYAIR E-SERIES SURGICAL LIGHTING SYSTEM Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair e-series surgical light and confirmed that the plastic ring had detached from the lighthead.The technician observed that the plastic ring was broken which is indicative of facility personnel bumping the lighthead into other pieces of equipment.The harmonyair e-series surgical light operator manual states (4-1), "caution - possible equipment damage: do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the technician replaced the lighthead, tested the lighting system, confirmed it to be operating according to specification and returned it to service.A 3-year complaint review indicates this to be an isolated event.A steris account manager offered in-service training on the proper use and operation of the harmonyair e-series surgical light, including the importance of not bumping the light into other equipment; however, the user facility declined.No additional issues have been reported.
 
Event Description
The user facility reported that prior to the start of a patient procedure, the plastic trim ring around the led indicator light on the bottom of the harmonyair e-series surgical lighthead detached and fell, entering the sterile field.The sterile field was reestablished, and the procedure was completed successfully.No report of injury or procedure delay.
 
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Brand Name
HARMONYAIR E-SERIES SURGICAL LIGHTING SYSTEM
Type of Device
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 Key11787125
MDR Text Key260247575
Report Number1043572-2021-00032
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 05/06/2021
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 04/06/2021
Initial Date FDA Received05/06/2021
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 Number1
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