MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-05 for LIONVILLE 800 SERIES * manufactured by Lionville Systems, Inc.
[21369344]
Staff reported med cart would not hold a charge. Biomed checked/replaced the battery. Unit still would not hold a charge. Biomed then pulled the charging unit out of the med cart and found the quick disconnect connector that leads to the batteries was burnt. The only fuse in the circuit, located between the battery and the power supply was not blown. Biomed voiced the concern that the way the charger is designed, a fire could occur in its circuitry without ever blowing the fuse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628169 |
| MDR Report Key | 1628169 |
| Date Received | 2010-03-05 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-27 |
| Report Date | 2009-08-27 |
| Date Reported to FDA | 2010-03-05 |
| Date Added to Maude | 2010-03-11 |
| 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 | 0 |
| 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 | LIONVILLE |
| Generic Name | MEDICATION ACUTE CARE CART |
| Product Code | BZN |
| Date Received | 2010-03-05 |
| Model Number | 800 SERIES |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIONVILLE SYSTEMS, INC |
| Manufacturer Address | 501 GUNNARD CARLSON DRIVE COATSVILLE PA 19320 US 19320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-05 |