FDA.reportPublic FDA data

MAUDE MDR 9812711

MDR report key
9812711
Report number
3004785967-2020-00348
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-10
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
1O1IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEMEDTRONIC NAVIGATION, INC (LITTLETON)OXOBI70000028230BI70000028230N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-100

Event Narratives#

N

Patient 1

PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. (B)(6). NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING. 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 IN A PROCEDURE. IT WAS REPORTED THAT AFTER TURNING THE SYSTEM ON AND WHILE MOVING TO THE OPERATING ROOM, THE SYSTEM BEEPED CONTINUOUSLY. AFTER CONNECTING THE UMBILICAL CORD, THE BEEPING CONTINUED AND THE SYSTEM FAILED TO BOOT UP COMPLETELY (GREEN BARS VISIBLE). THE SITE TRIED TO FIX THE ISSUE WITH A RE-BOOT THAT FROZE WITH TEXT "INITIALIZING SYSTEMS, PLEASE WAIT..." VISIBLE ON THE IMAGE ACQUISITION SYSTEM (IAS) MONITOR. THE SITE USED A DIFFERENT IMAGING SYSTEM THAT WAS AVAILABLE. AFTER A FEW UNSUCCESSFUL REBOOTS, THE SYSTEM BOOTED UP CORRECTLY. AFTER RUNNING THE CALIBRATIONS, THE SITE REPEATED BOOT UP PROCESS FIVE TIMES AND WAS NOT ABLE TO REPRODUCE ERROR. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE OCCURRED WHEN BOOTING UP THE SYSTEM WHEN PREPARING THE OPERATING ROOM (OR) FOR OPERATION.- MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM MALFUNCTIONED IN A SIMILAR MANNER. THE SYSTEM BEEPED CONTINUOUSLY AFTER BOOTING AND DIDN?T BOOT COMPLETELY. THEY RE-BOOT THE SYSTEM SEVERAL TIMES BUT THE IT NEVER GOT PAST THE ?BOOTING PHASE.? THE SYSTEM WAS LEFT UNPOWERED FOR 10 TO 15 MIN, AFTER WHICH THE SYSTEM TURNED ON NORMALLY AND WORKED WELL DURING THE PROCEDURE. THE ISSUE DIDN?T CAUSE DELAY, BUT SLOWED DOWN THE PREPARATIONS AND CAUSED CONCERNS. THERE WAS NO IMPACT ON PATIENT OUTCOME.