BASE SYS BI70002000 O-ARM SYS O2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for BASE SYS BI70002000 O-ARM SYS O2 manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[184279838] Onsite functional and visual examination was performed by a manufacturer representative. The power converter and the power tray were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184279839] Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the system was having intermittent boot problems. After the system was updated, the site said they experienced the pendant not connecting on boot up. They were able to shut down, unplug the image acquisition system (ias) and reboot the system and that temporarily resolved the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004785967-2020-00383
MDR Report Key9860125
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-26
Date Mfgr Received2020-03-19
Device Manufacturer Date2018-01-23
Date Added to Maude2020-03-20
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 ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC (LITTLETON)
Manufacturer Street300 FOSTER ST
Manufacturer CityLITTLETON MA 01460
Manufacturer CountryUS
Manufacturer Postal Code01460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBASE SYS BI70002000 O-ARM SYS O2
Generic NameINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Product CodeOWB
Date Received2020-03-20
Model NumberBI70002000
Catalog NumberBI70002000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC (LITTLETON)
Manufacturer Address300 FOSTER ST LITTLETON MA 01460 US 01460


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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