WI-BOX
Received Dec 22, 2022 · Event occurred Nov 25, 2022
Report 2184149-2022-00311 · MDR key 16036091
Device
Generic name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Manufacturer
St. Jude Medical, IncModel number
C12783Lot number
17031006
Product problems
- Communication or Transmission Problem
- Output Problem
- Communication or Transmission Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT CANCELLATION REMAINS UNKNOWN.
Description of Event or Problem
IN THE MIDDLE OF FFR MEASUREMENTS PROCEDURE, THERE WAS LOST CONNECTION AND ERROR MESSAGE 3202. THE WIBOX AND TRANSDUCER CABLE WERE EXCHANGED, HOWEVER THE PROCEDURE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.