MalfunctionFEN
ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI
Received Oct 18, 2013 · Event occurred Sep 19, 2013
Report 2243969-2013-00153 · MDR key 3482004
Device
Product problems
- Deflation Problem
Patient
Not reported
- Obstruction/Occlusion
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE VALVE KEPT EXPANDED AFTER DOING A MEASUREMENT, BLOCKING THE URINE'S FLOW.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS IS DEEMED A REPORTABLE MALFUNCTION. CUSTOMER NOTES WHEN REPORTING THAT THERE COULD BE SEDIMENTS FROM THE URINE. NO INJURY OR ADVERSE EFFECTS TO THE PATIENT WAS REPORTED. NO ADDITIONAL EVENT/PATIENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION HAS NOT BEEN RECEIVED TO DATE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).