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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 03/16/2012
Event Type  Malfunction  
Event Description

It was initially reported by a nurse that, when she plugged the handheld into the wall outlet on (b)(6) 2012, the handheld did not appear to be charging and was at 50% battery life. She then exchanged the ac power cord with the cord from a different handheld and plugged it in to the same wall outlet. The handheld started charging correctly; becoming fully charged after about 20 minutes. A replacement power cord was requested and the old ac adapter was returned for product analysis. Analysis was completed on (b)(4) 2012. An analysis was performed on the returned ac adapter. During the analysis the ac adapter was utilized in an attempt to power a known good handheld device; however this was unsuccessful. The power button did not indicate that the handheld was receiving power from the ac adapter. The cause for the reported complaint is associated with a defective power supply module; however the cause of the defect could not be determined during the analysis.

 
Event Description

Further analysis of the power supply, completed on (b)(6) 2012, identified that the most likely cause for the power supply failure is associated with a component failure caused by the contamination of an unknown green substance that was identified inside the case, on the pcb, and on the power supply components.

 
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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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2529946
Report Number1644487-2012-00964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number840144
OTHER Device ID NumberVERSION 8.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/07/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2008
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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