O-ARM 1000 IMAGING SYSTEM 3RD EDITION BI70000027230

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-12 for O-ARM 1000 IMAGING SYSTEM 3RD EDITION BI70000027230 manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[183171389] No patient information provided as no patient was involved in this concern. The unique identifier was not available at the time of reporting. (b)(6). The manufacturer representative went to the site to test the imaging system. The reported issue was not confirmed and no parts were replaced. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183171390] Medtronic received information regarding an imaging system. It was reported outside of a procedure that the pendant cable was replaced and then no x-rays in 2d mode were able to be made. No patient was present at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004785967-2020-00358
MDR Report Key9824835
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-12
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 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 1000 IMAGING SYSTEM 3RD EDITION
Generic NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Product CodeOXO
Date Received2020-03-12
Model NumberBI70000027230
Catalog NumberBI70000027230
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 2020-03-12

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