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 2020-03-12 for LOGIQ E BT12 manufactured by Ge Medical Systems (china) Co., Ltd (wuxi).
[185665644]
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. Legal manufacturer: (b)(4). A gehc service representative evaluated the equipment/event, and gehc's investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[185665645]
A customer reported a battery powered ultrasound system, the logiq e, was operating when they smelled smoke and suddenly the system started to burn from the battery side (underside). The customer tried to disconnect the battery but it was impossible, so a fire extinguisher was used to extinguish the fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710602-2020-00091 |
| MDR Report Key | 9824281 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2014-04-24 |
| Date Added to Maude | 2020-03-12 |
| 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-2130 / B4422 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOGIQ E BT12 |
| Generic Name | SYSTEM, IMAGING, DOPPLER, ULTRASOUND |
| Product Code | IYN |
| Date Received | 2020-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) |
| Manufacturer Address | NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE WUXI 214028 CH 214028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |