MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 7250

Device Problems Failure to Charge (1085); Loss of Power (1475)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

It was reported that the tablet switched off when unplugged from the power outlet despite having a fully charged battery.When the tablet was plugged to the power outlet, it could be switched on.Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.The tablet was returned to the manufacturer.Analysis of the device found no anomalies associated with the main battery.It was identified that the tablet could not charge the main battery, and as a result the device could not be powered using the main battery.The cause for the anomaly is associated with a loose battery cable to the motherboard.Once the cable was reseated, no further anomalies were identified.

Manufacturer Narrative

Udi# (b)(4).The device is indicated for heart failure an approved indication in the territory of distribution.Device manufacturing records were reviewed.Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.Device failure occurred, but did not cause or contribute to death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• 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: 4810311
• MDR Text Key: 5834958
• Report Number: 1644487-2015-04794
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

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: Other
• Device Model Number: MODEL 7250
• Other Device ID Number: VERSION 1.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1