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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 BI70000027120
Device Problems Calibration Problem (2890); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2021
Event Type  malfunction  
Manufacturer Narrative
No analysis has been completed at this time.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that they were unable to perform gain calibrations today.They were able to take 2d images, but when trying to do the fluoro and rad gain calibrations, the system would just make a beep noise and not do anything.They tried multiple reboots.When she called in, she was not in front of the system.There was no patient present.Additional information noted that when attempting to perform the calibrations the gantry was not able to move and the door would not open.The system makes a clicking noise when attempting to open the door and it will not move.The rotor will not move, and the system is down.The system will most likely get upgraded instead of replacing the issue.
 
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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 st
littleton MA 01460
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC (LITTLETON)
300 foster st
littleton MA 01460
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11536877
MDR Text Key243090910
Report Number3004785967-2021-00354
Device Sequence Number1
Product Code OXO
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/21/2021
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 NumberBI70000027120
Device Catalogue NumberBI70000027120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2021
Initial Date FDA Received03/21/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/19/2011
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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