MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-17 for VOYAGER N/A manufactured by International Biomedical, Ltd..
[4624124]
While removing old battery related to failure to charge because of open main fuse, as terminals were loosened, wiring harness shifted and went up in smoke. Biomed reviewed. Short from positive battery terminal to ground caused quick discharge of current. Contact was possibly made by tech's wrench. Tech says yes it did due to his reaction of the wire going up in smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3965835 |
| MDR Report Key | 3965835 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-04-08 |
| Report Date | 2014-07-17 |
| Date Reported to FDA | 2014-07-17 |
| Date Reported to Mfgr | 2014-07-30 |
| Date Added to Maude | 2014-07-30 |
| 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 | 3 |
| 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 | VOYAGER |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2014-07-17 |
| Model Number | VOYAGER |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL, LTD. |
| Manufacturer Address | 8508 CROSS PARK DRIVE AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-17 |