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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 01/15/2015
Event Type  Malfunction  
Event Description

The design history record was reviewed and the device passed all manufacturing and quality control inspection steps prior to shipment. No anomalies observed in review of the device history record.

 
Event Description

Product analysis for the tablet was completed and approved on 04/06/2015. An analysis was performed on the returned tablet and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

It was reported that the tablet device would not hold a charge for more than an hour. While plugged in to the power adaptor, the charging indicator was on and the tablet worked fine. The tablet device was returned to the manufacturer for analysis which identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
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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 Key4494098
Report Number1644487-2015-03780
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/15/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2015
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 Manufacturer01/26/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2014
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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