MalfunctionFEN
ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE
Received Apr 23, 2015 · Event occurred Mar 25, 2015
Report 1049092-2015-00219 · MDR key 4726804
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Lot number
1040600
Product problems
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE AUTO VALVE ON THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE WAS CLOSED AND COULD NOT BE REOPENED DURING USE. THE DEVICE WAS DISCONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVEN.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.