WI-BOX
Received Mar 17, 2026 · Event occurred Mar 2, 2026
Report 2184149-2026-00071 · MDR key 24619875
Device
Generic name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Manufacturer
Abbott MedicalModel number
C12783Catalog number
C12783
Lot number
7032408
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H2, H3, H6 ONE WI-BOX C12783 SN (B)(6) WAS RECEIVED INTO THE LAB FOR ANALYSIS WITH NO ACCESSORIES OR ORIGINAL PACKAGING AVAILABLE FOR INSPECTION. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE FIELD REPORTED EVENT CITING UNABLE TO ZERO PA WAS CONFIRMED. THE WI-BOX FAILED TO ESTABLISH COMMUNICATION AND ALL INDICATOR LED¿S (LIGHT EMITTING DIODES) WERE ILLUMINATED. ROOT CAUSE OF THIS ABNORMAL BEHAVIOR WAS ISOLATED TO A NON-SERVICEABLE SYSTEM LEVEL COMPONENT. THE BATCH RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.
Description of Event or Problem
DURING THE PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOT POSSIBLE TO GET AN AO PRESSURE. THE CORRECT ROOM WAS SELECTED, AND THE CORRECT WI BOX SN WAS POPULATED. THE PROCEDURE WAS CANCELLED AS A RESULT. THE PATIENT'S TREATMENT WAS MOVED TO MEDICAL THERAPY.