MalfunctionFEN
ADVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Dec 29, 2014 · Event occurred Nov 27, 2014
Report 1049092-2014-00663 · MDR key 4373540
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec, Inc.Model number
ABV320Lot number
130758
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LIQUID IS DRAINING THROUGH THE WALLS OF THE LIQUID RETURN VALVE CONNECTED TO THE URINARY CATHETER.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.