FDA.reportPublic FDA data

MAUDE MDR 9903338

MDR report key
9903338
Report number
3006544299-2020-00109
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACY RUEMPING
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BASE SYS BI70002000 O-ARM SYS O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMSOWBBI70002000BI70002000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000522. A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE MOBILE VIEWING STATION (MVS) WILL NOT POWER ON. IT WAS FOUND THAT THE DIN RAIL FUSES, F1, F2 FAILED. FUSES WERE REPLACED. THE IMAGING 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.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE IMAGING SYSTEM MOBILE VIEW STATION (MVS) WAS NOT POWERING ON. THE SYSTEM WAS PLUGGED IN OVERNIGHT, BUT WHEN GOING TO MOVE THE SYSTEM, THE GREEN POWER LINE WAS NOT ILLUMINATED NOR DID IT ILLUMINATE WHEN RE-PLUGGING THE SYSTEM. THEY PROCEEDED WITH THE CASE BY USING A C-ARM. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.