• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 04/16/2014
Event Type  Malfunction  
Event Description

The handheld analysis was completed on (b(4) 2014. No anomalies associated with the battery latch were identified. During the analysis it was identified that the main battery was swollen. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus causing the handheld to power off. No further anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2014. 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

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

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

 
Event Description

It was reported that the physician's handheld was hard to power on after being charged. Once the handheld powered on an interrogation was attempted at which time the handheld powered off. Upon restarting the handheld an error message was obtained indicating that the battery door latch was open. Troubleshooting confirmed that the latch was closed; however, it was noted that the door appeared to be bowed. The battery was confirmed to be normal in size and the handheld was stored at normal recommended temperatures. The battery confirmed to be at 100% and again shut down with the same error message being received upon restarting a second time. A new programming computer was provided to the physician and the handheld and flashcard were returned for analysis. Analysis is underway, but has not been completed to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key3812355
Report Number1644487-2014-01275
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
Device LOT Number1073773
OTHER Device ID NumberVERSION 8.1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/20/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/20/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-