MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-09 for DURADIAGNOST 712214 manufactured by Philips Healthcare (suzhou) Co., Ltd.
| Report Number | 3009529630-2019-00001 |
| MDR Report Key | 8878363 |
| Date Received | 2019-08-09 |
| Date of Report | 2019-07-12 |
| Date Mfgr Received | 2019-07-12 |
| Date Added to Maude | 2019-08-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTY LEPPERT |
| Manufacturer Street | NO.258, ZHONGYUAN ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal | 215024 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURADIAGNOST |
| Generic Name | SYSTEM, X-RAY, STATIONARY |
| Product Code | KPR |
| Date Received | 2019-08-09 |
| Model Number | 712214 |
| Catalog Number | 712214 |
| Lot Number | SN180054 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE (SUZHOU) CO., LTD |
| Manufacturer Address | NO.258, ZHONGYUAN ROAD SUZHOU INDUSTRIAL PARK SUZHOU 215024 CH 215024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-09 |