MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Failure to Charge (1085); Failure to Power Up (1476); Electronic Property Issue (2928)

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

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device (b)(4).

Event Description

It was reported that the nurse's tablet was not powering on.The tablet had been plugged into several wall outlets however it still did not power on.It was reported that the tablet is kept plugged in when not in use.It was noted that when the tablet was plugged in and the light on the power adapter was on however the charging indicator light on the tablet was not on.Troubleshooting was completed which included unplugging and re-plugging the power adapter into the wall.However this did not resolved the issue.A forced re-boot of the tablet was performed however the tablet would still not power on.The nurse was then provided with a replacement tablet.The suspect tablet and power adapter have not been received to date.No additional relevant information has been received to date.

• Brand Name: PROGRAMMING COMPUTER
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6023739
• MDR Text Key: 57322225
• Report Number: 1644487-2016-02341
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1