MalfunctionFEN
OM-4 URODYNAMIC PUMP
Received Feb 23, 1999 · Event occurred Jan 22, 1999
Report 2020483-1999-00002 · MDR key 211899
Device
Generic name
Water Infusion Pump
Manufacturer
Circon CorporationModel number
*Catalog number
50000-920
Lot number
NA
Product problems
- Pressure, insufficient
Patient
UNKNOWN
- Bleeding
Narrative
Description of Event or Problem
DURING AN ATTEMPT TO GET A URODYNAMIC PRESSURE READING, A NEGATIVE PRESSURE READING WAS OBTAINED. AT THE SAME TIME, BLEEDING WAS NOTICED COMING FROM THE PT'S URETHRA. THE PROCEDURE WAS STOPPED AND THE BLEEDING RESOLVED ITSELF. THERE WERE NO COMPLICATION AS A RESULT OF THIS EVENT.