POWERLED

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 2020-02-14 for POWERLED manufactured by Maquet Sas.

Event Text Entries

[180027574] The issue is being investigated by manufacturing site. : device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[180027575] On 10th february, 2020 getinge became aware of an issue with one of surgical lights - powerled. As it was stated, the bumper fell off on the patient during procedure when manipulating the light. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2020-00014
MDR Report Key9710844
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-14
Date of Report2020-03-19
Date Mfgr Received2020-02-27
Date Added to Maude2020-02-14
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 NamePOWERLED
Generic NameLIGHT, SURGICAL, CEILING MOUNTED
Product CodeFSY
Date Received2020-02-14
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 2020-02-14

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