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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTH SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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MEDTRONIC NAVIGATION, INC. STEALTH SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Data Back-Up Problem (2902)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2018
Event Type  malfunction  
Event Description
Medtronic o-arm with stealth software not connecting to picture archiving and communication system (pacs) properly after upgrade, delaying patient care. Manufacturer response for o-arm, medtronic stealth (per site reporter). Worked to connect system.
 
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Brand NameSTEALTH
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek cir.
louisville CO 80027
MDR Report Key8435728
MDR Text Key139313405
Report Number8435728
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2019
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer03/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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