MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for BREAS VIVO 50 215000 manufactured by Breas Medical Ab.
[144680707]
Fault description per the reporter "error 42, internal battery will not be detected". Analysis of the device log files, however, showed that the correct error code associated with the event was error code #18.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617566-2019-00014 |
| MDR Report Key | 8591501 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2012-03-14 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS ELISABETH CARLSSON |
| Manufacturer Street | FORETAGSVAGEN 1 |
| Manufacturer City | MOLNLYCKE, 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43533 |
| Manufacturer G1 | BREAS MEDICAL AB |
| Manufacturer Street | FORETAGSVAGEN 1 |
| Manufacturer City | MOLNLYCKE, 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREAS VIVO 50 |
| Generic Name | RESPIRATORY THERAPY DEVICE (HOMECARE USE) |
| Product Code | NOU |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-04-11 |
| Model Number | 215000 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREAS MEDICAL AB |
| Manufacturer Address | FORETAGSVAGEN 1 MOLNLYCKE, 43533 SW 43533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |