MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-17 for FIELD SURGICAL LIGHT 2410 MB * manufactured by Getinge/castle, Inc..
[183328]
Unit does not stop charging the lead acid batteries when full charge is reached. Batteries get very hot and swell, which ruins the batteries and requires their replacement. Mfr's manual states that batteries require 8 hrs to reach full charge but does not warn that unit must be unplugged. As reported by biomedical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019298 |
| MDR Report Key | 286100 |
| Date Received | 2000-07-17 |
| Date of Report | 2000-06-29 |
| Date Added to Maude | 2000-07-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIELD SURGICAL LIGHT |
| Generic Name | FIELD SURGICAL LIGHT |
| Product Code | KYT |
| Date Received | 2000-07-17 |
| Model Number | 2410 MB |
| Catalog Number | * |
| Lot Number | * |
| ID Number | NSN 6530-01-343-2033 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276849 |
| Manufacturer | GETINGE/CASTLE, INC. |
| Manufacturer Address | 7371 SPARTAN BLVD. EAST NORTH CHARLESTON SC 294188444 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-07-17 |