VECTRA GENISYS 4 CH COMBO
Received Jan 14, 2010 · Event occurred Nov 13, 2009
Report 1022819-2009-00180 · MDR key 1579993
Device
Product problems
- Loss of Power
- Fail-Safe Problem
Patient
Not reported
- Burning Sensation
Narrative
Additional Manufacturer Narrative
DEVICE INVOLVED IN INCIDENT PERTAINS TO RECALL. UPON EVALUATION OF THE DEVICE BY CHATTANOOGA GROUP ENGINEERING DEPARTMENT, IT WAS DETERMINED THAT THE DEVICE CONTAINED SHORTED CIRCUITRY ON CHANNEL 4 OF THE STIMULATORY PCB AT Q322, Q318, Q319 AND Q328. THIS SHORTAGE OCCURRED DUE TO OVERVOLTAGE RESULTING FROM IMPROPER SOFTWARE VERSIONS CONTROLLING STIMULATORY OUTPUT. THE DEVICE HAS BEEN REPAIRED AND THE SOFTWARE HAS BEEN UPDATED TO REQUIREMENTS SET FORTH IN FDA RECALL.
Description of Event or Problem
DEVICE SHUT OFF, FAILING SAFE. PATIENT REPORTED FEELING "A COUPLE OF BEE STINGS". CLINICIAN REPLACED ELECTRODES TWICE AND "IT HAPPENED AGAIN".
Remedial action
- Recall