MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INC. PHILIPS X-RAY; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problems Failure to Power Up (1476); Device Inoperable (1663); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 01/09/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: PHILIPS X-RAY
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS INC.; 595 miner road; cleveland OH 44143
• MDR Report Key: 7479246
• MDR Text Key: 107133325
• Report Number: 7479246
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Other Device ID Number: SITE NUMBER: 4005244699
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR