inforMED
MalfunctionFEN

LABORIE T-DOC-7FD

Received Jun 3, 2019 · Event occurred Mar 11, 2019

Report 8662250 · MDR key 8662250

Device

Generic name

Device, Cystometric, Hydraulic

Model number

T-DOC-7FD

Lot number

181680

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

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 BLUETOOTH DEVICE. SENSOR READINGS WERE INCORRECT DURING CALIBRATION SO CATHETER WAS REPLACED. THE SECOND CATHETER WORKED WELL.