MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTEGRIS CV (CESAR-POWERPACK-VISUB-NICOL); SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722030

Device Problems Image Display Error/Artifact (1304); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed phillips will inform the fda.

Event Description

Philips has received through (b)(6) a report submitted by a customer.In this report, the customer reported that ¿during a revision operation of an implantable cardioverter defibrillator (icd), no filming with the system was possible (foot switch does not work as on friday of the previous week for filming).The same problem had occurred on friday of the previous week; hospital medical technology was informed, was on site and stated that the problem had been solved.During the procedure, after 10 minutes of fluoroscopy with the icd already exposed, no fluoroscopy was possible.A complete shutdown of the system was done and then at least fluoroscopy was possible again.Significant delay of the operation time (thus increasing risk of infection).The affected system (philips integris cv) dates from 1996 and is in end-of-service status.As a result, the manufacturer can no longer guarantee the availability of spare parts.So far, however, all malfunctions could still be repaired.According to the original reinvestment planning, the device was to be replaced this year as part of the ppp conversions.Due to the delays in construction that have occurred in the meantime, the device is currently still in operation.From our point of view, the device should not and can no longer be operated¿.Because of the allegation on potential harm this report is being submitted.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

The issue of no x-ray possible was solved by the hospital medical technology by restarting the system.No patient harm was reported.Log files are not available for the system due to its age (in use since 1996); therefore philips has not been able to further investigate the cause of the reported issue.In the report submitted by the customer to the (b)(4), the customer had also reported that the system had got stuck during a clinical procedure in right anterior oblique 30 degrees and could not be driven back.No patient harm was reported.Philips solved the issue performing a geometry calibration and adjusting the c-arc bearing.Geometry calibration is to be performed on a regular basis.The customer does not have a contract for preventive maintenance with philips.Previous to this complaint, philips had informed the customer on two occasions about the end of life of the system.Since (b)(6) 20018 the system is no longer in use.No further actions will be taken.

• Brand Name: INTEGRIS CV (CESAR-POWERPACK-VISUB-NICOL)
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 7995600
• MDR Text Key: 124984663
• Report Number: 3003768277-2018-00080
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K984545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722030
• Device Catalogue Number: 722030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1