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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR G SERIES SURGICAL LIGHTING SYSTEM
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STERIS CORPORATION - MONTGOMERY HARMONYAIR G SERIES SURGICAL LIGHTING SYSTEM Back to Search Results
Device Problem Loss of Power (1475)
Patient Problem No Code Available (3191)
Event Date 03/26/2020
Event Type  malfunction  
Manufacturer Narrative
A dta service technician arrived on site to inspect the lighting system and found the spindle commutator for the lighthead was not operating properly resulting in the reported event.The lighting system has been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported that a lighthead on their harmonyair g series surgical lighting system turned off during a patient procedure.A procedure delay occurred as facility personnel reset the lighting system to restore function of the lighting system.The procedure was completed successfully.No report of injury.
 
Manufacturer Narrative
A dta service technician replaced the spindle, tested the lighting system, confirmed it to be operating according to specification, and returned it to service.Since the replacement spindle was installed, no further issues have been reported.
 
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Brand Name
HARMONYAIR G SERIES SURGICAL LIGHTING SYSTEM
Type of Device
SURGICAL LIGHTING SYSTEM
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery, al
MDR Report Key10034149
MDR Text Key199501331
Report Number1043572-2020-00024
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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