MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-05 for VIVID I manufactured by G.e Medical Systems Israel Ltd..
[182120731]
No report of patient involvement. Udi: not applicable. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Ge healthcare's investigation is ongoing. Legal manufacturer: (b)(4). Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[182120732]
A customer reported that a fire started from a battery-powered ultrasound device, the vivid i. They reported ignition, sparks and smoke from the rear/back of the vivid i. The fire was extinguished by a fire extinguisher (c02 initially and then sprayed water because it could not be extinguished). At the time of the event the vivid i was on a cart and was battery powered (no ac).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615849-2020-00001 |
| MDR Report Key | 9671392 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2015-05-10 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 W INNOVATION DR MAIL DROP: RP-B4422 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVID I |
| Generic Name | DIAGNOSTIC ULTRASOUND SYSTEM |
| Product Code | ITX |
| Date Received | 2020-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | G.E MEDICAL SYSTEMS ISRAEL LTD. |
| Manufacturer Address | NATIV HA'OR STREET NO. 1 HAIFA 3508510 IS 3508510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |