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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) Back to Search Results
Model Number S7
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 08/19/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: device manufacture date updated to proper value.
 
Manufacturer Narrative
No procode, common device name, udi and/or 510(k) provided as this device is not released for distribution in the united states. This complaint was initially assessed as a non-reportable malfunction with the information available. The mdr decision was reversed based on evaluation of returned axiem system on (b)(6) 2018. The hardware investigation of the returned axiem box found that the reported event was related to an electrical issue. Port 4 stayed amber when an instrument was inserted in the port, and tracking details reported not used. Eminterface reported a fault on the instrument. Port 8 was eratic and intermittent when first inserted the instrument, after 5 minutes tracking details stayed red with a poor signal error. Eminterface reported that coil 2 was not functioning. The reported event was confirmed. This issue was documented in a medtronic navigation hardware anomaly tracking database. A medtronic representative went to the site to test the equipment and replace the axiem box. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A medtronic representative reported that a port did not verify upon using the em controller. They used a different working port. There was no patient present when this issue was identified.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE H10)
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key7229509
MDR Text Key103062203
Report Number1723170-2018-00464
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
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,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2013
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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