BERNOULLI MANAGEMENT SYSTEM
Received Mar 10, 2015 · Event occurred Sep 17, 2014
Report 2936999-2015-00210 · MDR key 4587814
Device
Generic name
Oxinet Iii And Lifegard Vue
Manufacturer
Cardiopulmonary Corp.Model number
3274Catalog number
3274
Product problems
- Mechanics Altered
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
COVIDIEN REFERENCE: (B)(4). THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE REPORTED MALFUNCTION WAS VERIFIED. A DATABASE ERROR WAS IDENTIFIED AND THE LATEST SOFTWARE WAS LOADED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED TESTING AND WAS PLACED BACK IN SERVICE.
Description of Event or Problem
IT WAS REPORTED THAT THE OXINET III ALARM MANAGEMENT SYSTEM LOCKED -UP WITH A SYSTEM LOADING MESSAGE. PATIENTS WERE BEING MONITORED BY THE OXIMETERS IN THE ROOMS. THERE WAS NO REPORT OF PATIENT SERIOUS INJURY OR DEATH AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
(B)(4).