O-ARM BI70002000

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 2020-03-23 for O-ARM BI70002000 manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[184540694] Other relevant device(s) are: product id: bi71000175, serial/lot #: (b)(4). A medtronic representative went to the site to test the equipment. The manufacturer representative replaced the charger enclosure. The imaging system then passed the system checkout and was found to be fully functional. The charger enclosure was returned to the manufacturer for analysis. The charger enclosure was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184540695] Medtronic received information regarding an imaging system. It was reported the battery level indicators were decreasing faster than normal. This issue was noted outside of a procedure, and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004785967-2020-00394
MDR Report Key9866835
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Device Manufacturer Date2016-02-29
Date Added to Maude2020-03-23
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 NameO-ARM
Generic NameINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Product CodeOWB
Date Received2020-03-23
Returned To Mfg2020-03-12
Model NumberBI70002000
Catalog NumberBI70002000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-03-23

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