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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 Mechanical Problem (1384); Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the relay and varistor were causing the motor to stop prematurely.Replaced the relay and varistor and the system regained functionality.Systems checkout was performed and system was functioning as intended.
 
Event Description
Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure.It was reported that the system was not taking a full 3d spin and would stop after about a quarter or half spin was captured.The system was also not raising all the way up.There was no patient impact reported.
 
Manufacturer Narrative
Additional information: it was determined there was an unconfirmed accidental radiation occurrence due to early termination of acquisition.No defect in an electronic product or failure to comply per 21 cfr 1003 was discovered.The investigation concluded that the issue was due to hardware.Relay and varistor components replaced to resolve.Number of people exposed: 1 - patient total number of people in or unknown.Estimated absorbed or effective dose information is not available.If information is provided in the future, a supplemental report will be issued.
 
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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
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7693652
MDR Text Key114153339
Report Number1723170-2018-03491
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/21/2018
Initial Date FDA Received07/17/2018
Supplement Dates Manufacturer Received06/21/2018
Supplement Dates FDA Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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