MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-06 for WALKAWAY96 PLUS B1018-284 manufactured by Beckman Coulter.
| Report Number | 2919016-2019-01002 |
| MDR Report Key | 9287658 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-21 |
| Date Facility Aware | 2019-10-21 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2016-01-07 |
| Date Added to Maude | 2019-11-06 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HELLEN FOX |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742313 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY96 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPTIBILITY SYSTEM |
| Product Code | LRG |
| Date Received | 2019-11-06 |
| Model Number | B1018-284 |
| Catalog Number | B1018-284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-06 |