MalfunctionJZT
VIDAS
Received May 24, 2001 · Event occurred Mar 19, 2001
Report 1950204-2001-00009 · MDR key 335400
Device
Generic name
Immunoflurometric Equipment
Manufacturer
Biomerieux, Inc.Model number
NACatalog number
W2010
Lot number
NA
Product problems
- Complete Blockage
- Replace
- Device Issue
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER CALLED TO REPORT THAT THEY WERE HAVING PROBLEMS WITH PATIENT RESULTS. A FIELD SERVICE ENGINEER WAS SENT TO THE SITE AT WHICH TIME THE INSTRUMENT FAILED A PUMP DIAGNOSTIC TEST (OCT TEST). THE PUMP WAS REPLACED AND THE OLD PUMP WAS CONFIRMED TO HAVE A CLOGGED PUMP TUBE.
Remedial action
- Inspection
- Notification
- Repair