MalfunctionLEJ
SUNDASH
Received Jun 17, 2014 · Event occurred Apr 21, 2014
Report 2311923-2014-00004 · MDR key 3982776
Device
Product problems
- Electrical /Electronic Property Problem
- Nonstandard Device
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WIRING IN POWER HARNESS SHORTED.
Additional Manufacturer Narrative
AN 806 SUBMITTED TO THE (B)(4) DISTRICT OFFICE OF THE FDA.
Remedial action
- Recall