LUCEA 10 ARD568602971

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-06 for LUCEA 10 ARD568602971 manufactured by Maquet Sas.

Event Text Entries

[178210043] The issue is being investigated by manufacturing site. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[178210044] On (b)(6) 2019 getinge became aware of an issue with lucea 10 light. As it was stated, the connection between main tube and suspension arm was cracked. There was no injury reported. Taking into consideration the worst case scenario which is the detachment of examination light, we decided to report the issue based on the potential.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2019-00354
MDR Report Key9423927
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-06
Date of Report2020-03-25
Date of Event2019-11-11
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-06-19
Date Added to Maude2019-12-06
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 ContactMR. PASCAL JAY
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Manufacturer G1MAQUET SAS
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUCEA 10
Generic NameDEVICE, MEDICAL EXAMINATION, AC POWERED
Product CodeKZF
Date Received2019-12-06
Model NumberARD568602971
Catalog NumberARD568602971
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET SAS
Manufacturer AddressPARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-06

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