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 2020-02-27 for 3SC-RS PROBE W/VIVID IQ manufactured by Ge Medical Systems (china) Co., Ltd (wuxi).
[181238196]
Patient information could not be obtained due to country privacy laws. The initial reporter did not provide the date of incident. Vivid iq udi: (b)(4). 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: parallel design sas (hcs nice) - (b)(4). Device evaluation anticipated, but not yet begun
Patient Sequence No: 1, Text Type: N, H10
[181238197]
A customer reported that a 3sc-rs ultrasound probe, when used with a vivid iq, had interference when activating the color doppler and pw doppler. This occurred while attempting to perform a bedside echocardiographic exam at a coronary icu when the interference appeared suddenly making it impossible to perform the exam. The patient had acute dysfunction due to thrombosis of a mitral mechanical prosthesis, which was undiagnosed due to the interference, who ended up dying for lack of diagnosis hours after the failed attempt to perform the exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710602-2020-00071 |
| MDR Report Key | 9765688 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2018-08-07 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3SC-RS PROBE W/VIVID IQ |
| Generic Name | ULTRASOUND IMAGING SYSTEM |
| Product Code | IYN |
| Date Received | 2020-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Death | 2020-02-27 |