LIGHT SOURCE, LED 3000 72204011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-30 for LIGHT SOURCE, LED 3000 72204011 manufactured by Smith & Nephew, Inc..

Event Text Entries

[115592378] Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[115592379] It was reported that the device light shuttled down as it started to heating up and thus simulated a blank/dark image. No significant delay or patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2018-00121
MDR Report Key7731882
Date Received2018-07-30
Date of Report2018-08-24
Date Mfgr Received2018-08-23
Date Added to Maude2018-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJIM GONZALES
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123585706
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLIGHT SOURCE, LED 3000
Generic NameCAMERA, TELEVISION, SURGICAL, WITH AUDIO
Product CodeFWC
Date Received2018-07-30
Returned To Mfg2019-03-18
Catalog Number72204011
Lot Number000000000015070848
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-30

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