MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-14 for 2008K * manufactured by Fresenius Medical Care North America.
[3371135]
Due to electrical interference/artifact that occurred every few seconds, it was impossible to accurately view patient's underlying rhythm. Monitor counted interference as pvcs (premature ventricular contractions). When dialysis machine put on hold, the patient's nsr (normal sinus rythm) reappeared and the pvcs were non-existent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921567 |
| MDR Report Key | 2921567 |
| Date Received | 2013-01-14 |
| Date of Report | 2013-01-14 |
| Date of Event | 2012-11-15 |
| Report Date | 2013-01-14 |
| Date Reported to FDA | 2013-01-14 |
| Date Added to Maude | 2013-01-18 |
| 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 | 2008K |
| Generic Name | SYSTEM, HEMODIALYSIS |
| Product Code | MQS |
| Date Received | 2013-01-14 |
| Model Number | 2008K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 920 WINTER STREET, SUITE A WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-14 |