VOLISTA STANDOP ARDVST229037A ARD568811960

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 2020-02-19 for VOLISTA STANDOP ARDVST229037A ARD568811960 manufactured by Maquet Sas.

Event Text Entries

[181999009] Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[181999010] On 14th of february getinge became aware of an issue with the volista device. As stated by the customer cracks on underside glass of the devices appeared. Based on provided photographic evidence we concluded that due to the breakage occurrence, some part could have fallen off the device. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling into the sterile field might be a source of contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2020-00021
MDR Report Key9724823
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2020-02-14
Date Mfgr Received2020-02-14
Date Added to Maude2020-02-19
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 NameVOLISTA STANDOP
Generic NameLIGHT, SURGICAL, CEILING MOUNTED
Product CodeFSY
Date Received2020-02-19
Model NumberARDVST229037A
Catalog NumberARD568811960
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 2020-02-19

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