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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 01/27/2015
Event Type  Malfunction  
Event Description

It was reported that the programming tablet has been charging for a long time and the battery light is still flashing amber. The tablet was unplugged and immediately powered off and would not power back on. The tablet was plugged back into the power cord and the battery light illuminated red and then flashed amber again. It was reported that the tablet was last used on (b)(6) 2014 and that it had been plugged into a power source for a long time. After 10 minutes the tablet was again removed from the power source and immediately powered off and would not power back on. The site was provided a new programming tablet and the non-functional tablet was received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

 
Event Description

Product analysis was completed for the tablet device. A visual analysis inside the tablet case identified a loose cable that connects the main battery to the motherboard. This condition can cause an intermittent electrical connection that can prevent the tablet from operating on battery power and charging the main battery. With the tablet in its ¿as received¿ condition no anomalies associated with the tablet performance were noted during testing. The tablet performed according to functional specifications.

 
Manufacturer Narrative

The loose cable was identified as a possible cause for the battery not holding its charge, but the failure could not be confirmed.

 
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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 Key4542038
Report Number1644487-2015-03968
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2015
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 Manufacturer02/02/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2013
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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