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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
Catalog Number BI70000027230
Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.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 source cover was damaged.Replaced the dual fan that is attached to the rotor cover plate.Systems checkout was performed and system was functioning as intended.
 
Event Description
Medtronic received information regarding an imaging device being used outside of procedure.It was reported that the system had a damaged source cover.The louver plate was bent, damaging one of the fans.No patient present.
 
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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
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7702396
MDR Text Key114424455
Report Number1723170-2018-03583
Device Sequence Number1
Product Code OXO
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K092564
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/19/2018
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 Catalogue NumberBI70000027230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2018
Initial Date FDA Received07/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2011
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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