MalfunctionORT
BIS
Received Nov 16, 2017 · Event occurred Oct 1, 2017
Report 2936999-2017-05625 · MDR key 7039684
Device
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CORRECTION: (NAME, EMAIL), (PHONE). THE UNIT WAS RETURNED FOR EVALUATION AND THE REPORTED CONDITION WAS CONFIRMED. THE UNIT WAS RETURNED IN A CONDITION THAT COULD NOT BE USED TO FIND A ROOT CAUSE FOR THE REPORT. THE UNIT COULD NOT BE REPAIRED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, THE UNIT WAS SMOKING. THERE IS NO ALLEGATION OF PATIENT INVOLVEMENT.