MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for PHILIPS X-RAY manufactured by Philips Medical Systems Inc..
[107133324]
Patient Sequence No: 1, Text Type: N, H10
[107133325]
Patient arrived in catheter lab for a fistulagram procedure. Procedure started at 1022. The procedure to the right fistula vein (angiography, thrombectomy and percutaneous transluminal angioplasty (pta) was completed at 1046). Patient had received 1mg versed (1002), 50 mcg fentanyl (1002), 50 mcg fentanyl (1104) and 5000 units of heparin (1036). During the procedure to the right fistula artery (after angiography and thrombectomy) x-ray equipment stopped working. Message said equipment was no longer connected to server. Several attempts were made to reboot machine but it was unsuccessful. Philips was called. The rest of the procedure was aborted with no harm to patient. Physician will reschedule to complete procedure. Patient taken back to his room. This is from the philips field service engineer that fixed the problem: cath lab experienced a problem with the host pc computer/the main system computer. According to system logfiles, the host pc will intermittently stop communicating with the system, or the software on it will intermittently freeze. Then after a complete system reboot the system will work without any problems for 1 or 3 days until the failure came back. I was never able to duplicate the problem nor did i witness the problem. During the diagnostic process, it was hard to determine that the host pc was defective because the error logs appeared to stop logging at the time of the incident. So in the beginning, we replaced some power supplies, and an ethernet switch, and the problem kept coming back. As i escalated the problem during the diagnostics, i sent a detailed logfile to the philips business unit in europe and to our regional national support specialist, and they then determined that the host pc was defective. We replaced the host pc, and i got confirmation from the staff that the system has been stable since the repair. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7479246 |
| MDR Report Key | 7479246 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-01-09 |
| Report Date | 2018-04-26 |
| Date Reported to FDA | 2018-04-26 |
| Date Reported to Mfgr | 2018-04-26 |
| Date Added to Maude | 2018-05-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS X-RAY |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-05-02 |
| ID Number | SITE NUMBER: 4005244699 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS INC. |
| Manufacturer Address | 595 MINER ROAD CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |