WI-BOX¿ WIRELESS SOLUTION
Received Dec 22, 2022 · Event occurred Dec 12, 2022
Report 2184149-2022-00299 · MDR key 16040814
Device
Product problems
- Communication or Transmission Problem
- No Apparent Adverse Event
- Communication or Transmission Problem
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.
Description of Event or Problem
DURING A CASE, THE CONNECTION OF THE WI-BOX WITH THE HEMODYNAMIC SYSTEM DROPPED OUT. THE ISSUE WAS ISOLATED TO A NON-ABBOTT DEVICE. THE PROCEDURE WAS CANCELLED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE PROCEDURE WAS RESCHEDULED AND COMPLETED THE NEXT DAY. THE WI-BOX IS FULLY FUNCTIONING IN THE (B)(6).
Description of Event or Problem
DURING A CASE, THE CONNECTION OF THE WI-BOX WITH THE HEMODYNAMIC SYSTEM DROPPED OUT, RESULTING IN CANCELLATION OF THE PROCEDURE.