MalfunctionIMJ
CHATTANOOGA
Received Jun 19, 2015 · Event occurred Jun 4, 2015
Report 9616086-2015-00015 · MDR key 4861665
Device
Product problems
- Loose or Intermittent Connection
- Device Emits Odor
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPLAINT RECEIVED FROM CUSTOMER THAT ALLEGES "MONODE SMOKING, HAS A BURNING SMELL". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVAL. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH. NO INDICATION DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.
Additional Manufacturer Narrative
FDA ACKNOWLEDGED RECALL #Z-0121-2016 IN PROCESS AS A RESULT OF THIS AND SIMILAR INCIDENCES.
Remedial action
- Recall