MalfunctionFEN
T-DOC AIR CHARGED DUALSENSOR CATHETER
Received Oct 22, 2019 · Event occurred Mar 20, 2019
Report 9219010 · MDR key 9219010
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Laborie Medical Technologies Canada UlcModel number
7FDCatalog number
7FD
Lot number
181304
Product problems
- Output Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
URINARY CATHETER WAS INSERTED INTO PATIENT'S BLADDER AND CONNECTED TO COMPUTER VIA BLUE TOOTH DEVICE. SENSOR READINGS WERE INCORRECT DURING CALIBRATION SO CATHETER WAS REPLACED. THE SECOND CATHETER WORKED WELL.