FDA.reportPublic FDA data

MAUDE MDR 9873491

MDR report key
9873491
Report number
3006544299-2020-00098
Event key
0
Event type
3
Date of event
2020-03-03
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1O-ARM O2 IMAGING SYSTEMINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMSOWBBI70002000BI70002000N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-240

Event Narratives#

N

Patient 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: KIT SVC O2 BI71000548 COMP IAS SER (B)(4). THE ISSUE WAS RESOLVED OVER THE PHONE. SYSTEM CHECKOUT WAS NOT NECESSARY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM COULD NOT TAKE X-RAY. THE ISSUE WAS RESOLVED OVER PHONE SUPPORT. THE SYSTEM WAS REBOOTED, AND THE EQUIPMENT RAN SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.