ABVISER-INTRA ABD PRESSURE MONITOR DEVICE
Received Jun 9, 2014 · Event occurred May 13, 2014
Report 1049092-2014-00182 · MDR key 3921509
Device
Generic name
Device, Vystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Catalog number
ABV301
Lot number
UNK
Product problems
- Display Difficult to Read
- Device Difficult to Program or Calibrate
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT DURING USE OF THE DEVICE COMPLAINANT REPORTS PREVIOUSLY GETTING A WAVEFORM PATTERN ADN THEN NOT GETTING AN ACCURATE WAVEFORM PATTERN. EDUCATION WAS PROVIDED ON HOW TO ZERO OUT THE TRANSDUCER AND ALSO THE SUGGESTION OF REPLACING IT. COMPLAINANT VERIFIED TRANSDUCER MOUNTED AT MID AXILLARY. LASTLY, THERE WERE NO REPORTS OF UNTOWARD EFFECT TO PATIENT.
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 COMPLAINANT VERIFIED NO LOT NUMBER AVAILABLE. NO ADDITIONAL PATIENT/EVENT DETAIL HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.