MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for ALLURA XPER FD10 722003 manufactured by Philips Healthcare.
[145226447]
When the investigation is completed a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[145226448]
Philips has received through (b)(4) a report submitted by a healthcare professional (b)(4). In this report it was reported:? The system stopped responding. A reset of the touch screen module had no effect, so the system had to be completely switched off. The incident occurred during patient operation around 10:00 a. M. On (b)(6) 2019. According to dr. ? Cer, various cardiac catheters had to be replaced. The event was classified as a patient hazard.? Philips has initiated an investigation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2019-00039 |
| MDR Report Key | 8611375 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| 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 | 2019-05-15 |