MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-30 for FRESENIUS 2008K manufactured by Fresenius Usa.
[15559091]
Cracked housing on electrical plug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013298 |
| MDR Report Key | 1520658 |
| Date Received | 2009-10-30 |
| Date of Report | 2009-10-30 |
| Date Added to Maude | 2009-11-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS 2008K |
| Generic Name | NONE |
| Product Code | FII |
| Date Received | 2009-10-30 |
| Returned To Mfg | 2009-11-04 |
| Model Number | 2008K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA |
| Manufacturer Address | WALNUT CREEK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-10-30 |