MalfunctionIME
CHATTANOOGA
Received Apr 23, 2015 · Event occurred Apr 9, 2015
Report 9616086-2015-00009 · MDR key 4725287
Product problems
- Thermal Decomposition of Device
- Fire
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
COMPLAINT RECEIVED FROM CLINICIAN THAT ALLEGES "CUSTOMER STATES THAT THE UNIT CAUGHT FIRE AND THE BACK POWER CORD PLUG ALONG WITH THE BACK PANEL OF THE UNIT WAS BURNT UP. NO INJURY OCCURRED". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.