WI-BOX PSU KIT
Received Dec 9, 2025
Report 2184149-2025-00212 · MDR key 23764388
Device
Generic name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Manufacturer
Abbott MedicalModel number
C12785Catalog number
C12785
Product problems
- Power Problem
- Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PRODUCT'S LOT NUMBER COULD NOT BE OBTAINED; THEREFORE THE PRIMARY DI NUMBER IS PROVIDED (D4), BUT FULL UDI INFORMATION IS NOT AVAILABLE.
Description of Event or Problem
DURING THE FFR PROCEDURE, THERE WAS INTERFERENCE AND IT WAS UNABLE TO ZERO. THE PROCEDURE WAS ABANDONED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H2, H3, H6, H11. 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 OF INTERFERENCE AND UNABLE TO ZERO COULD NOT BE DETERMINED.