inforMED
MalfunctionFEN

N/A

Received Aug 21, 2017 · Event occurred Sep 13, 2013

Report 6807554 · MDR key 6807554

Device

Generic name

Device, Cystometric, Hydraulic

Manufacturer

Mfr Unknown

Product problems

  • Device Operates Differently Than Expected

Patient

31 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

BLADDER PRESSURE MONITORING DEVICE MALFUNCTION. DISCOVERED THAT PREDETERMINED AMOUNT OF NS INSTILLED INTO BLADDER DID NOT RETURN/DRAIN. REMOVED DEVICE FROM FOLEY CATHETER AND >300 ML DRAINED FROM BLADDER.