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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 03/20/2015
Event Type  Malfunction  
Event Description

Product analysis was completed for the tablet device on 04/23/2015. The tablet was received without a serial cable. An analysis of the tablet was performed and a visual analysis identified damage to the tablet back cover and usb port. The cause of the damage is unknown, but can be attributed to mishandling of the device. Additionally, functional testing of the tablet identified that it would not power on. The cause for the anomaly is associated with incorrect power and ground wire connections to the wi-fi card. The condition created an electrical short and prevented the tablet from powering on. No further anomalies were identified. Analysis determined that this was definitely not an out of box failure. There was obvious physical damage to the tablet as evidenced by a separated cover and damaged port. This was likely due to the device being dropped. The port was damaged, but still functional, and was used during testing. Even though the port was functional, the damage could definitely have contributed to the ¿unable to open port ¿error which was observed. With the wires reversed, the tablet could not power on. The tablet was also visibly used. There were archived databases present. The tablet would not have functioned at all with the wires connected as it was received. It is likely that after the tablet was dropped, the user incorrectly connected the wires. The company field representative stated that he went to the office to troubleshoot, was able to turn on the tablet and received the ¿unable to open port¿ error. He took the tablet with him that day and it was not dropped. Based on this, it is unclear how the wires became reversed leading to a failure to power on the tablet.

 
Event Description

It was reported that the usb port of the tablet device was damaged and was missing a component. Attempts to perform interrogations resulted in error message stating ¿unable to open port. ¿ the tablet device has been returned to the manufacturer where analysis is currently underway.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4685212
Report Number1644487-2015-04440
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/07/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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