CHATTANOOGA
Received Feb 11, 2017 · Event occurred Feb 1, 2017
Report 9616086-2017-00003 · MDR key 6324830
Device
Product problems
- Fire
- Device Inoperable
- Fire
- Device Inoperable
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NOT RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "(B)(6) WE RECEIVED A REPORT OF BROKEN CABLES ON THE UNIT AND A NOTE THAT THE CUSTOMER HAD USED DUCT TAPE TO REPAIR THEM. I ASKED FOR MORE INFORMATION AND DID NOT RECEIVE A RESPONSE UNTIL (B)(6) STATING THAT THE UNIT HAD CAUGHT FIRE". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, PERMANENT IMPAIRMENT OR DEATH.
Additional Manufacturer Narrative
PRODUCT WAS RETURNED FOR REVIEW. WHEN UNPACKED UNIT WAS WELL PACKED, BUT HAD SEVERAL PARTS BROKEN LIKE BOTTOM DRAWER, TOP DISPLAY BACK COVER WAS BROKEN, MONODE ONE SIDE TERMINAL PIN WAS BROKEN. UNIT MONODE (02200002) WAS TESTED FOR CONTINUITY AND PASS BUT STILL THE MONODE ONE SIDE TERMINAL WAS BROKEN SO UNABLE TO CONNECT IT TO UNIT; UNIT WAS TESTED AS IS AND AFTER 30 SECONDS RUNNING AT LEVEL # 4 WITH 150 WATTS OUTPUT THE UNIT DIGITAL MONITOR DISPLAY SHOWED: "INFORMATION # 119" MAKING REFERENCES TO CHECKING THE ELECTRODES AND WILL NOT OPERATE NORMALLY. ROOT CAUSE: MONODE ONE SIDE TERMINAL BROKE OFF.