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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 04/11/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the physician's handheld device will not power on. This occurs whether or not the device's charging cable is plugged in. No additional pertinent information has been received to date.

 
Event Description

The suspect handheld device and associated flashcard were received by the manufacturer on 05/05/2016, and product analysis was subsequently completed. For the returned handheld, visual inspection of the device showed that the screen was cracked. Additionally, the lock button was in the locked position, thus the initial attempt to power on the handheld was unsuccessful. The lock button was moved to the unlocked position, and the device was successfully powered on. An attempt to advance past the welcome screen was performed but was unsuccessful, as the touchscreen was unresponsive. The cracked screen was replaced with a known good screen, and the initial setup process was performed. No further issues were noted with device charging, generator interrogations or diagnostics. The cause of the cracked screen was mechanical stress. The analysis performed on the returned flashcard showed no identified issues. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

 
Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 inadvertently omitted section of product analysis results that pertained to portions of device not returned.

 
Event Description

Further review of product analysis results revealed that the ac adapter cable was not returned with the handheld. As product analysis was not completed on this portion of the device, the possibility the failure to power on was from an issue with the power cord could not be eliminated. Follow up with the physician's office indicated that the power cable could not be located and returned to the manufacturer for product analysis. It has not been returned to date. No additional pertinent information has been received to date.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
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 Key5626315
Report Number1644487-2016-00932
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 04/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1075837
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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