MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for USYSTEMS INVENIA GEN 2 manufactured by Hcs Sunnyvale.
[39536192]
Ge healthcare's investigation is ongoing. A supplemental report will be provided when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[39536193]
It was reported that a primary lesion marker for a breast ultrasound scan allegedly moved posterior unexpectedly on a subsequent reading of the study. In this particular case, the reading physician was the same physician who performed the study and therefore the issue was obvious to the user. It is unknown whether or not the reading device was manufactured by ge healthcare. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954903-2016-00001 |
| MDR Report Key | 5464394 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-01-19 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2014-10-23 |
| Date Added to Maude | 2016-02-26 |
| 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 | MR JAMES GILES |
| Manufacturer Street | 3000 N GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482089 |
| Manufacturer G1 | HCS SUNNYVALE |
| Manufacturer Street | 447 INDIO WAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | USYSTEMS INVENIA GEN 2 |
| Generic Name | AUTOMATED BREAST ULTRASOUND |
| Product Code | PAA |
| Date Received | 2016-02-26 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HCS SUNNYVALE |
| Manufacturer Address | 447 INDIO WAY SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |