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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL

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MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL Back to Search Results
Model Number 9734056
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Patient Involvement (2645)
Event Date 10/17/2018
Event Type  malfunction  
Manufacturer Narrative
No procode, common device name and/or 510k provided as this device is not released for distribution in the united states. A medtronic representative went to the site to test the equipment. Testing revealed that the monitor was flickering. The monitor and external cable were replaced, and the issue resolved. The system then passed the system checkout and was found to be fully functional. The monitor was returned to the manufacturer for analysis. Analysis found that the reported issue could not be duplicated. The returned monitor had scratches on the display but was otherwise functional. When connected to a known good system, the monitor displayed a good image with none of the reported flickering. No problem was found. The cable was returned to the manufacturer for analysis. Analysis found that reported issue could be duplicated. A continuity test of the returned cable revealed an open from pin 10 of the h26 connector to pin 16 of the fischer connector. Analysis found that the reported event was related to an electrical issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that a noise was noted with the monitor. A "boo" sound was also heard. When touching the cable, the issue of the sound was resolved, but the noise remained the same. There was no patient present when this issue was identified. The external cable was returned for analysis and an open was found.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8325610
MDR Text Key136325128
Report Number1723170-2019-00604
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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