MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-06 for FRESENIUS 2008 T 2008T manufactured by Fresenius Medical Care.
[4120218]
Patient became unresponsive while on machine. Patient rinsed back with normal saline. No pulse noted. Cpr initiated. Patient sent to hospital per acadian ambulance. Patient returned to clinic on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3546026 |
| MDR Report Key | 3546026 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-07-08 |
| Date Facility Aware | 2013-07-08 |
| Report Date | 2013-08-06 |
| Date Reported to Mfgr | 2013-08-07 |
| Date Added to Maude | 2014-01-03 |
| 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 | 3 |
| 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 | FRESENIUS 2008 T |
| Generic Name | 2008T |
| Product Code | FKP |
| Date Received | 2013-09-06 |
| Model Number | 2008T |
| Lot Number | NA |
| ID Number | 8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE |
| Manufacturer Address | BOSTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-09-06 |