MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-21 for LOGIQ P9 H42872LB manufactured by Ge Ultrasound Korea, Ltd..
| Report Number | 9710090-2019-00004 |
| MDR Report Key | 9356923 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2019-11-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 W INNOVATION DR MAIL DROP: RP-2130 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOGIQ P9 |
| Generic Name | ULTRASONIC IMAGING SYSTEM |
| Product Code | IYN |
| Date Received | 2019-11-21 |
| Model Number | H42872LB |
| Lot Number | LP9003946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE ULTRASOUND KOREA, LTD. |
| Manufacturer Address | 9, SUNHWAN-RO 214BEON-GIL JUNGWON-GU SEONGNAM-SI 462-807 KS 462-807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-11-21 |