MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-10 for BIOMERIEUX BACTERIAL MICROBIAL DETECTION SYSTEM manufactured by Biomerieux.
[16746750]
The biomerieux bact/alert microbial detection system presented with code 710 and message "incubator module temporarily unavailable while power up initialization takes place. The code then went away only to repeat again several more times. Error code 1 "power fault in incubation module" also appeared. Incubator #5 associated with the controller contained culture bottles from 32 apheresis collections. Culture bottles had to be relocated to another incubator. Per the biomerieux tech, the voltage on the power supply was out of tolerance causing the power interruption.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024258 |
| MDR Report Key | 2462509 |
| Date Received | 2012-02-10 |
| Date of Report | 2012-02-10 |
| Date of Event | 2012-01-27 |
| Date Added to Maude | 2012-02-22 |
| 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 BACTERIAL MICROBIAL DETECTION SYSTEM |
| Generic Name | BACT ALERT |
| Product Code | JTA |
| Date Received | 2012-02-10 |
| 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 | 2012-02-10 |