ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI
Received Jul 22, 2013 · Event occurred Jun 24, 2013
Report 2243969-2013-00024 · MDR key 3247624
Device
Product problems
- No Device Output
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
GREEN BALLOON IN THE TRANSDUCER PART REMAINED INFLATED SO THEY COULD INJECT FLUID BUT NONE CAME OUT SO THEY COULD NOT OBTAIN READINGS. ONCE THEY APPLIED A NEW SET UP, THE NEW ONE WORKED WITHOUT DIFFICULTY. IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS ON THE PT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PT HAD SURGERY FOR SMALL BOWEL OBSTRUCTION. IN ICU AT 1800, ABVISOR APPLIED, WORKED WELL. AT 0100, THE DEVICE APPEARED TO BE "CLOGGED." THE BALLOON IS ACTUALLY INFLATED. NEW ABVISOR APPLIED AND NO PROBLEM. IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS ON THE PT. THIS IS DEEMED A REPORTABLE MALFUNCTION FOR POTENTIAL SERIOUS INJURY (URINE RETENTION). REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNK. SO THE DATE USED WAS THE DATE WE BECAME AWARE.