MalfunctionKZB
ANOXOMAT MARK II
Received May 29, 2007 · Event occurred Oct 31, 2006
Report 867575 · MDR key 867575
Device
Generic name
Culture System, Anaerobic
Manufacturer
Spiral Biotech, Inc.Model number
MARK IICatalog number
*
Lot number
*
Product problems
- Product Quality Problem
- Repair
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DEVICE WAS SET UP AND TESTED. CATALYST SUPPLIED WOULD NOT PRODUCE ANAEROBIC CONDITIONS IN CANNISTERS. MANUFACTURER TECHNICAL SUPPORT SUGGESTED ORDERING MORE CATALYST. ORDERED IN NOVEMBER, DECEMBER AND JANUARY. WOULD NOT PASS QC. IN FEBRUARY MANUFACTURER REQUESTED RETURN OF THE DEVICE FOR EVALUATION. RETURNED TO USER IN MARCH WITH NO PROBLEMS FOUND. CATALYSTS CONTINUED TO FAIL. IN APRIL NOTIFIED BY MANUFACTURER THAT BAD CATALYST MAY HAVE BEEN RELEASED. MANUFACTURER PROMISED CERTIFIED CATALYST. NONE RECEIVED. UNIT NOT USABLE AFTER SEVEN MONTHS.