MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for ALLURA XPER FD10 722010 manufactured by Philips Healthcare.
[131337447]
When the investigation has been completed philips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[131337448]
Philips has received through the danish medicines agency a report (dkma ref. : (b)(4)) submitted by a customer. In this report the customer reported:? Acute primary patient with an embolism in the heart is located on the table in room 5. We have started the procedure. During the procedure, before we have entered the wire into the vessel, then the x-ray equipment will not rotate around the patient. The system is then re-booted/a cold shot down and hereafter the system is working again?. Philips has initiated an investigation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2018-00099 |
| MDR Report Key | 8189060 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2010-08-09 |
| Date Added to Maude | 2018-12-21 |
| 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 | 0 |
| Brand Name | ALLURA XPER FD10 |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-12-21 |
| Model Number | 722010 |
| Catalog Number | 722010 |
| 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 | 2018-12-21 |