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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); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/30/2018
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.It was reported that the door pin receiver on the imaging system was replaced.The imaging system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that, while outside of a procedure, the door pin on the imaging system was found to be loose.It was noted that the screws on the door pin receiver could not be tightened.The reported issue was discovered during a planned maintenance (pm).There was no patient present when this issue was identified.No additional information was provided.
 
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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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7307510
MDR Text Key101375174
Report Number1723170-2018-00931
Device Sequence Number1
Product Code OXO
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K050996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/01/2018
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 Radiologic Technologist
Device Model NumberBI-700-00027-120
Device Catalogue Number9732719
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2018
Initial Date FDA Received03/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2008
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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