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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
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MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE Back to Search Results
Model Number BI-700-00027-120
Device Problems Electrical /Electronic Property Problem (1198); Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the charging board voltages were outside of acceptable voltages.All 3 charger boards were replaced and the system returned to normal functionality.The imaging system then passed the system checkout and was found to be fully functional.A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that this was not a software issue.Analysis found that the software functioned as designed.Two battery charger boards were returned to the manufacturer for analysis.Investigation confirmed reported problem "unable to take shots." analysis found that battery charger 1 and 2's j3 boards had a minimum of two solder runs blown and damaged components in the surrounding area.Due to condition of pcba fixture and system testing was not performed.Pcba damaged due to electrical event.Leaking capacitors were present.Analysis found that the reported event was related to an electrical issue.
 
Event Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the system was unable to take 2d shots or take a 3d spin.Attempted both the foot and handswitch but neither would successfully work.Had green lines of communication but reported receiving an error code 25.Issue occurred intra/peri-operatively with less than one hour delay to surgical time.There was no reported impact to patient outcome.
 
Manufacturer Narrative
The motor battery charger was returned to the manufacturer for evaluation.After functional testing, performance testing and visual/physical examination it was observed and confirmed the reported issue.The board failed visual inspection due to leaky capacitors.All leds were lit during bench test and passed functional test.Charging, x-ray, communication was motion was successful.3d and 2d images were acquired.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the system was unable to take 2d shots or take a 3d spin.Attempted both the foot and handswitch but neither would successfully work.Had green lines of communication but reported receiving an error code 25.Issue occurred intra/peri-operatively with less than one hour delay to surgical time.There was no reported impact to patient outcome.
 
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Brand Name
O-ARM 1000 IMAGING SYSTEM
Type of Device
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton MA 01460
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton MA 01460
Manufacturer Contact
maxwell roth
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7774229
MDR Text Key116864370
Report Number1723170-2018-03975
Device Sequence Number1
Product Code OXO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBI-700-00027-120
Device Catalogue Number9732719
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age48 YR
Patient Weight91
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