HARMONYAIR M SERIES SURGICAL LIGHTING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for HARMONYAIR M SERIES SURGICAL LIGHTING SYSTEM manufactured by Steris Corporation - Montgomery.

MAUDE Entry Details

Report Number1043572-2020-00013
MDR Report Key9771404
Report SourceUSER FACILITY
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Date Added to Maude2020-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR, OH
Manufacturer CountryUS
Manufacturer Phone3927453
Manufacturer G1STERIS CORPORATION - MONTGOMERY
Manufacturer Street2720 GUNTER PARK DRIVE EAST
Manufacturer CityMONTGOMERY, AL
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHARMONYAIR M SERIES SURGICAL LIGHTING SYSTEM
Generic NameLIGHTING SYSTEM
Product CodeFSY
Date Received2020-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION - MONTGOMERY
Manufacturer Address2720 GUNTER PARK DRIVE EAST MONTGOMERY, AL US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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