MalfunctionIMJ
CHATTANOOGA INTELECT SWD 100 PKG
Received May 17, 2019 · Event occurred Apr 22, 2019
Report 9616086-2019-00022 · MDR key 8619281
Device
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
HEALTH PROFESSIONAL: UNKNOWN, OCCUPATION: UNKNOWN. THE CUSTOMER DID NOT INDICATE THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION; IT WAS SERVICED BY A THIRD-PARTY VENDOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT "THE UNIT STOPPED WORKING AND WAS SMOKING". THERE WAS REPORTEDLY NO PATIENT INJURY. FURTHER DETAILS HAVE BEEN REQUESTED.