MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-21 for ANTEK NITROGEN ANALYZER 703 (720C AND 771C) 99042 AND 99044 manufactured by Antek Instruments, Inc..
[67688]
User reported that response was too low for known concentration of nitrogen. The problem was turned over to the biomedical (maintenance) group for the university.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1641354-1997-00001 |
| MDR Report Key | 108067 |
| Report Source | 05 |
| Date Received | 1997-07-21 |
| Date of Report | 1997-07-21 |
| Date of Event | 1997-07-07 |
| Date Mfgr Received | 1997-07-07 |
| Device Manufacturer Date | 1987-10-01 |
| Date Added to Maude | 1997-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTEK NITROGEN ANALYZER |
| Generic Name | CLASS I IN VITRO DIAGNOSTIC DEVICE |
| Product Code | CCI |
| Date Received | 1997-07-21 |
| Model Number | 703 (720C AND 771C) |
| Catalog Number | 99042 AND 99044 |
| Lot Number | 1987 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106210 |
| Manufacturer | ANTEK INSTRUMENTS, INC. |
| Manufacturer Address | 300 BAMMEL WESTFIELD RD. HOUSTON TX 77090 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-21 |