MalfunctionIPF
7550
Received Aug 27, 2009 · Event occurred Jul 28, 2009
Report 1022819-2009-00176 · MDR key 1495627
Device
Product problems
- Power Conditioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
NON INJURY INCIDENT. COMPLAINANT STATES THAT STIMULATION WILL JOLT WHENEVER PRE-MODIFIED WAVEFORM IS SELECTED.
Additional Manufacturer Narrative
CHATTANOOGA GROUP ENGINEERING EVAL OF THE DEVICE FINDS NO ANOMALIES ON CHANNEL 1 & 2 OUTPUT. CHANNEL 3 & 4 WAS FOUND TO HAVE SHORTED CIRCUIT. DEVICE WAS REPAIRED AND RE-TESTED WITH NO FURTHER ANOMALIES FOUND. CHATTANOOGA GROUP IS PERFORMING FURTHER ANALYSIS TO DETERMINE IF THE SEVERITY AND FREQUENCY OF THIS OCCURRENCE IS WITHIN EXPECTED LEVELS.