O-ARM 1000 IMAGING SYSTEM BI70000027120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-20 for O-ARM 1000 IMAGING SYSTEM BI70000027120 manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[184317813] Patient information not provided due to canadian patient privacy regulations. A medtronic representative went to the site to test the equipment. Testing revealed that the system control board and the generator cover was adjusted to restore functionality. The imaging system then passed the system checkout and was found to be fully functional. Other relevant device(s) are: product id: bi-500-01093, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184317834] Medtronic received information that, while in a spinal fusion, the imaging functionality displayed a red x. It was reported that the imaging system was powered on and initialization was completed. The imaging system was then plugged into the viewing station of the imaging system, the transport brake button was pressed and the issue then occurred. Hard restarts as well as disconnecting and reconnecting the lemo did not restore functionality. The surgeon opted to complete the procedure without the use of the imaging system. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5


[187766192] A software analysis was initiated as part of the investigation. Analysis found that the issue was unrelated to the software of the imaging system. The software of the imaging system functioned as designed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004785967-2020-00382
MDR Report Key9860037
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-28
Date Mfgr Received2020-02-28
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 NameO-ARM 1000 IMAGING SYSTEM
Generic NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Product CodeOXO
Date Received2020-03-20
Model NumberBI70000027120
Catalog NumberBI70000027120
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 2020-03-20

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