ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE
Received Mar 4, 2015 · Event occurred Jan 30, 2015
Report 1049092-2015-00129 · MDR key 4579988
Device
Manufacturer
Convatec Inc.Model number
ABV301Product problems
- Calibration Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A NURSE REPORTED THAT THE DEVICE WAS PLACED IN THE PT ON (B)(6) 2015 AND AFTER MANY TRIES, IT WAS NOTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS IT PRESENTED BOTH NEGATIVE VALUES AND HIGH VALUES IN THE SAME TIME. THE NURSE FURTHER REPORTED THAT THE DEVICE WAS REMOVED ON THE SAME DAY.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.