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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 01/01/2015
Event Type  Malfunction  
Event Description

It was reported that the handheld device would only work while it was charging. Once the handheld was disconnected to the power adaptor, the screen went blank. The handheld device has not been returned to date.

 
Event Description

The handheld computer and the software flashcard were retuned to the manufacturer on 03/16/2015. Analysis of the handheld computer found no anomaly associated with the performance of the handheld¿s display. The handheld was returned without a battery cover. As a result, the handheld would not power ¿on¿. A known good battery cover was used to complete testing. One of the leaf springs associated with the main battery terminal on the main pcb was bent which rendered the main battery unable to establish electrical contact with the handheld, which did not permit the battery recharge using the ac power. Also the handheld was unable to be powered using the main battery. Once the leaf spring was bent back into place, the handheld performed according to specifications. Analysis of the flashcard identified no anomalies associated with flashcard software. The flashcard and software performed according to functional specifications.

 
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 Key4519346
Report Number1644487-2015-03851
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1063834
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/29/2013
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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