MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for PHILIPS MICRODOSE SI (MODEL: L50) 714047 manufactured by Philips Medical Systems.
[185564726]
0n (b)(6) 2017 15:35:23 the performance of the system, at the time of the event, i. E. February 4th 2016, has been evaluated and confirmed to be working as per specification, and performing as designed for its intended use. A thorough investigation has been performed concluding that there was not malfunction of the device that could impact image quality. However, it has been noted that the quality control procedures, performed by the customer, in some cases have not been properly performed. A risk analysis was performed and revealed no unacceptable risk. This issue is further monitored and trended. There is no indication of malfunction of the device that could impact the image quality at the time of the event. As a result of the investigation user training at site was planned to ensure quality control procedures are performed effectively. During the visit to the customer by application specialist, evaluation of image quality was made together with the customer and different image processing filters were demonstrated this report was originally filed under 3007056120 2016 00002 it was submitted as an e-submitter file. Submission summary core id: ci1469127553813. 1543759@fdsuv08651_te1. Batch id: 3009307584-20160721115014. Date entered: (b)(6) 15:05:48 edt 2016 summary: passed: 1, failed: 0 report list: report number: 3009307584-2016-00001, passed. Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[185564727]
On (b)(6) 2016, a patient's breast screening was conducted using philips microdose si (model: l50) system. The acquired image was reviewed by radiologist on a siemens pacs reviewing workstation. Radiologist reviewed the image and no clinical finding is reported. The patient felt something in the breast and came back for consultation and then the patient underwent diagnostic scanning on another microdose si (model: l50 system) on (b)(6) 2016 and radiologist reported clinical finding in the breast image
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-01992 |
| MDR Report Key | 9897912 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-06-23 |
| Date Added to Maude | 2020-03-30 |
| 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. DUSTY LEPPERT |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS MICRODOSE SI (MODEL: L50) |
| Generic Name | FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Product Code | MUE |
| Date Received | 2020-03-30 |
| Model Number | 714047 |
| Catalog Number | 714047 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |