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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 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

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MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE Back to Search Results
Model Number BI-700-00028-120
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.The interface (umbilical) cable was replaced to resolve the reported issue.The imaging system then passed the system checkout and was found to be fully functional.The interface (umbilical) cable has not been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that, while outside of a procedure, the interface (umbilical) cable was difficult to plug/unplug into the viewing station of the imaging system and imaging system.There was no patient present when this issue was identified.No additional information was provided.
 
Manufacturer Narrative
The interface (umbilical) cable was returned to the manufacturer for evaluation.Testing found that the logical length tests failed on the ethernet portion of the cable.
 
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Brand Name
O-ARM 1000 IMAGING SYSTEM 3RD EDITION
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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7248733
MDR Text Key99248056
Report Number1723170-2018-00572
Device Sequence Number1
Product Code OXO
UDI-Device Identifier00643169353428
UDI-Public00643169353428
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092564
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 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberBI-700-00028-120
Device Catalogue NumberBI70000028120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2015
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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