MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-17 for BRAEMER AF 920-WIRELESS manufactured by Braemar.
[1132936]
The pt, was wearing a cardiac event monitor provided by ecardio diagnostics. The monitor transmitted two recordings in 2009. The first at 1641 which was time/date stamped at 1030. The second recording which transmitted at 1644 which time-date stamped at 1630 am. The recordings did not transmit until 10 hours after the event was recorded and then transmitted in reverse order -according to the time-date stamp info. This is a wireless monitor and should have transmitted at the time of the recording. The pt expired. Dates of use: 30 days. Event abated after use stopped or dose reduced? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012803 |
| MDR Report Key | 1481609 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-09-17 |
| Date of Event | 2009-08-22 |
| Date Added to Maude | 2009-09-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BRAEMER AF 920-WIRELESS |
| Generic Name | EVOLUTION |
| Product Code | MWJ |
| Date Received | 2009-09-17 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAEMAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-09-17 |