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.
[131484583]
When the investigation has been completed philips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[131484584]
Philips has received through (b)(6) a report submitted ((b)(4)) by a customer. In this report the customer reported:? The x-ray tube in room 5 had been repaired, updated during the day of (b)(6) 2018. Was reported ready for use. We re-booted the system at the beginning of the night shift due to that the table was hard to operate (a creaking sound). Hereafter there was an acute patient on the table without x-ray problems. After some hours a new acute patient arrive. Before this patient was brought onto the table we discovered that the table was floating? Meaning that it was moving by the leased touch. Therefore it was not possible to complete the kag/pci on this very bad acute patient. Had to move the patient to another room which took approx. 10 min. Normally? When treating acute patients? It takes approx.. 5 min when the patient arrive at the room until the procedure can start?. Philips has initiated an investigation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2018-00098 |
| MDR Report Key | 8188893 |
| 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 |