O-ARM BI70000028120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-30 for O-ARM BI70000028120 manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[185524651] A medtronic representative went to the site to test the equipment. Testing revealed the battery appeared to have overheated due to corrosion of battery terminal causing resistance/poor contact. All 38 system batteries, tray 4, contact terminals and wiring were replaced. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185524652] Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the image acquisition system (ias) had a thermal event. The biomedical engineer pulled out the middle battery on the top tray which was overheating to resolved the issue. This took place in a storage room. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004785967-2020-00424
MDR Report Key9897990
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2014-11-22
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Product CodeOXO
Date Received2020-03-30
Model NumberBI70000028120
Catalog NumberBI70000028120
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-30

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