MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-29 for ANOXOMAT MARK II * manufactured by Spiral Biotech, Inc..
[642167]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 867575 |
| MDR Report Key | 867575 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-29 |
| Date of Event | 2006-10-31 |
| Report Date | 2007-05-29 |
| Date Reported to FDA | 2007-05-29 |
| Date Added to Maude | 2007-06-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANOXOMAT MARK II |
| Generic Name | CULTURE SYSTEM, ANAEROBIC |
| Product Code | KZB |
| Date Received | 2007-05-29 |
| Returned To Mfg | 2007-02-27 |
| Model Number | MARK II |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 849182 |
| Manufacturer | SPIRAL BIOTECH, INC. |
| Manufacturer Address | AN ADVANCED INSTRUMENTS INC. C TWO TECHNOLOGY WAY NORWOOD MA 02062 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-29 |