MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-04-07 for FRESENIUS 2008K manufactured by Fresenius Usa, Inc.
[1576798]
Follow up from cardiac arrest during dialysis. On functional test of dialysis machine following adverse event the machine eval failed alarm test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1655773 |
| MDR Report Key | 1655773 |
| Report Source | 99 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-04-05 |
| Date of Event | 2010-03-27 |
| Date Facility Aware | 2010-03-29 |
| Report Date | 2010-04-05 |
| Date Reported to FDA | 2010-04-06 |
| Date Reported to Mfgr | 2010-04-06 |
| Date Added to Maude | 2010-04-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS 2008K |
| Generic Name | DIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2010-04-07 |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA, INC |
| Manufacturer Address | 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US 94598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-04-07 |