LUCEA 40 ARD568601997

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-26 for LUCEA 40 ARD568601997 manufactured by Maquet Sas.

Event Text Entries

[187917565] Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[187917566] On (b)(6) 2019 getinge became aware of an issue with one of the light? Lucea. As it was stated the plastic casing of the lucea was broken and due to this was removed from the room. Customer did not provide any information about any parts falling down however on the provided photographic evidence lack of some particles was noticed, therefore we could suspected that some of them potentially fell down. Taking under consideration collected up to date information we decided to report this case based on potential as any parts falling from the device might cause contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2020-00056
MDR Report Key9884702
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2019-03-12
Date Added to Maude2020-03-26
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 40
Generic NameDEVICE, MEDICAL EXAMINATION, AC POWERED
Product CodeKZF
Date Received2020-03-26
Catalog NumberARD568601997
Device AvailabilityY
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 2020-03-26

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