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

Model Number MODEL 250

Device Problems Break (1069); Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING 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 Key: 4685212
• MDR Text Key: 5801825
• Report Number: 1644487-2015-04440
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1