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 2016-09-16 for ALLURA XPER FD20 BIPLANE (FD20/15) 722058 manufactured by Philips Healthcare.
[54892153]
When the investigation has been completed philips will inform the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54892154]
Philips received a complaint from the customer in which they stated that they started a procedure for treatment on a patient with an aneurysm, during the treatment the system stopped working. The system was restarted several times, finally they were able to finish the procedure. This restarting caused a delay in the treatment of the patient. After the treatment the patient had no feeling in left hand and left foot. Geometry movements were partially unavailable and the image on the screen turned purple, system was not generating x ray.
Patient Sequence No: 1, Text Type: D, B5
[55124478]
Patient Sequence No: 1, Text Type: N, H10
[72825715]
Philips investigated the complaint and came to the following conclusion: investigation of the logfiles and information of the philips field service engineer showed that following series of events occurred: the frontal live image on the flexvision screen (left image) went black at 53 minutes after start of procedure. To restore the quality of the image to expected level the system was restarted (warm restart) after 55 minutes after the start of the procedure. The restart was completed at 14:57 minutes. This did not result in full recovery of the image quality: the image appeared on the screen, with a purple background. In a second attempt, to improve the image quality, the operating physician initiated a? Cold restart? Of the system. After this? Cold restart? The quality of both images, left and right was restored to expected level. This? Cold? Or complete restart of the system however had triggered a limitation in the geometry movement. When a movement or current is measured during startup, the stand will not be powered on, because of safety risks. Another cold restart was necessary to regain full recovery of both the image and the geometry function. The procedure was continued after 1 hour and 29 minutes (after start of the procedure) and the stent was placed successfully. After 4 hours and 49 minutes the stent placement was successfully terminated. The first issue (the? Black screen? ) was identified from the log files (at 14. 54? Signal lost on channel 0? ) to be located in the connection between the ip pc frontal image and the frontal live or left image on the display of the monitor. Since it could not be reproduced and the cause cannot be identified from the log files, so therefore we cannot determine the cause for the lost connection. The following contributing factors (probable root causes) were identified: a rare issue with the flexvision monitor (not reproducible electronic signal transmission error): the black screen issue could be due to a connection problem between the ip pc frontal image and left image on the display of the monitor. No errors related to purple screen were detected in the logfiles. Because the issues could not be reproduced by the fse, this is characterized as a single event. Both issues were? One- offs?? , no similar issues were found during investigation, and the combination is certainly the first one to be reported. The cold restart in combination with not cooling down of the system caused the i/speed zero error resulting in a limitation in the geometry movement in section 3. 2. 3. Of the instructions for use the following is mentioned:? Do not switch the system power off immediately after the system has been used. The x-ray tube should be allowed to cool down for several minutes, especially after heavy usage?.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2016-00084 |
| MDR Report Key | 5955580 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-09-09 |
| Date Mfgr Received | 2016-09-09 |
| Device Manufacturer Date | 2014-10-02 |
| Date Added to Maude | 2016-09-16 |
| 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 FD20 BIPLANE (FD20/15) |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER |
| Product Code | OBW |
| Date Received | 2016-09-16 |
| Model Number | 722058 |
| Catalog Number | 722058 |
| 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 | 1. Other | 2016-09-16 |