MULTICARE PLATINUM 8-004-0017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-18 for MULTICARE PLATINUM 8-004-0017 manufactured by .

Event Text Entries

[133854584] It was reported that the c-arm is "slightly moving downward after reach maximum height. " no injury reported. A field engineer was dispatched to the site. A recommendation was made by technical support to check the power control board and c-arm actuator motor assembly. It was reported on (b)(6) 2019 that the field engineer "has not been able to get an appointment to complete the job. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220984-2019-00009
MDR Report Key8261549
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-01-18
Date of Report2018-12-21
Date of Event2018-12-21
Date Mfgr Received2019-02-11
Device Manufacturer Date2014-02-01
Date Added to Maude2019-01-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN FORNIERI
Manufacturer Street36 & 37 APPLE RIDGE ROAD
Manufacturer CityDANBURY CT 06810
Manufacturer CountryUS
Manufacturer Postal06810
Manufacturer Phone2037318491
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMULTICARE PLATINUM
Generic NameSTEREOTACTIC BREAST BIOPSY SYSTEM
Product CodeIZH
Date Received2019-01-18
Model Number8-004-0017
Catalog Number8-004-0017
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.