MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-08 for BIOMERIEUX BACT/ALERT MICROBIAL DETECTION SYSTEM manufactured by Biomerieux.
[2462643]
The biomerieux bact/alert microbial detection sys presented with a message "instrument 2 is not responding. " the controller screen on instrument 2 was completely black and no power was going to the controller. The incubators associated with the controller contained culture bottles from 172 phoresis collections. Loss of power to the controller for the culture bottles. Contributing factors may have been that the power to the bact controller was disrupted causing the internal ups (battery mode) to supply power. The internal circuitry failed to allow the ups to switch back to ac mode when the main power was resumed. This caused the battery to be completely drained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023406 |
| MDR Report Key | 2371957 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-12-08 |
| Date of Event | 2011-11-05 |
| Date Added to Maude | 2011-12-16 |
| 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 | 0 |
| 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 | BIOMERIEUX BACT/ALERT MICROBIAL DETECTION SYSTEM |
| Generic Name | BACT ALERT |
| Product Code | JTA |
| Date Received | 2011-12-08 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX |
| Manufacturer Address | BOX 15969 DURHAM NC 27704096 US 27704 0969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-08 |