MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for POWERLOOK AMP WITH SECONDLOOK DIGITAL GE V7.2 DSC010-01-US manufactured by Icad, Incorporated.
[97380768]
The oem field service engineer returned to customer site and installed the cad license and the system is working properly.
Patient Sequence No: 1, Text Type: N, H10
[97380769]
A customer site indicated that no cad markings were reported from the cad after processing patient images. The oem mammography field service engineer (fse) did not apply the cad license after installing the cad software. This resulted in the site not having cad marks on cases for some time. No patient injury or adverse event was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225671-2018-00001 |
| MDR Report Key | 7183668 |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2017-12-14 |
| Device Manufacturer Date | 2017-06-14 |
| Date Added to Maude | 2018-01-11 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN DELUCIA |
| Manufacturer Street | 98 SPIT BROOK ROAD, SUITE 100 |
| Manufacturer City | NASHUA NH 03062 |
| Manufacturer Country | US |
| Manufacturer Postal | 03062 |
| Manufacturer Phone | 6033091945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POWERLOOK AMP WITH SECONDLOOK DIGITAL GE |
| Generic Name | SECONDLOOK DIGITAL |
| Product Code | MYN |
| Date Received | 2018-01-11 |
| Model Number | V7.2 |
| Catalog Number | DSC010-01-US |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICAD, INCORPORATED |
| Manufacturer Address | 98 SPIT BROOK ROAD, SUITE 100 NASHUA NH 03062 US 03062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |