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 2019-04-17 for ALLURA XPER FD10 722003 manufactured by Philips Healthcare.
[142225197]
When the investigation has been completed philips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[142225198]
Philips has been reported that a patient received 11 gy of radiation. According to the information received the patient passed away after the procedure. As of the date of this report, no allegation has been made to philips that the 11gy radiation contributed to the patient death. Philips has started an investigation for this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2019-00033 |
| MDR Report Key | 8522924 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-08 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2009-09-04 |
| Date Added to Maude | 2019-04-17 |
| 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 | VEENPLUIS 4-6 P.O. BOX 10.000 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal | 5680 DA |
| 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 | 3 |
| Brand Name | ALLURA XPER FD10 |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2019-04-17 |
| Model Number | 722003 |
| Catalog Number | 722003 |
| 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 HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |