MalfunctionFFT
DIVERSATEK HEALTHCARE
Received Sep 25, 2024 · Event occurred Jul 1, 2024
Report 20299879 · MDR key 20299879
Device
Generic name
Electrode, Ph, Stomach
Manufacturer
Diversatek Healthcare, Inc.Model number
ZAI-BS-01Catalog number
ZAI-BS-01
Lot number
004802
Patient
74 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT WAS HAVING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) AND PLACEMENT OF 24-HOUR IMPEDANCE PH CATHETER. WHEN CALIBRATING THE CATHETER PRIOR TO PLACEMENT, AN IMPEDANCE ERROR MESSAGE APPEARED ON THE RECORDER. TRIED MULTIPLE CATHETERS AND DIFFERENT RECORDERS. ALL HAD THE SAME ERROR MESSAGE.