MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problem Failure to Read Input Signal (1581)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation is completed a follow-up report will be sent to the fda.

Event Description

Philips has received through (b)(4) a report submitted by a healthcare professional (b)(4).In this report it was reported: ¿the system stopped responding.A reset of the touch screen module had no effect, so the system had to be completely switched off.The incident occurred during patient operation around 10:00 a.M.On (b)(6) 2019.According to dr.Ücer, various cardiac catheters had to be replaced.The event was classified as a patient hazard.¿ philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.Analysis of the system log files did not show any malfunction that could have caused the ep touch screen module (tsm) to freeze and subsequently the system not responding.According to the system log files, the system was not in use for 1 hour and 20 minutes.Reset of the allura system did not have effect as the ep cockpit system is not powered via the allura system, but has its own mains power.Only when the ep cockpit system was restarted the problem was solved and it did not reoccur.The patient was anaesthetized and the examination was continued normally after the reboot without any effect on the patient's state of health.The system was checked on site and no malfunction was identified.A problem similar to the occurrence reported was reproduced when the keyboard video mouth switch through with the ep tsm is connected to the ep cockpit cabinet was disconnected.The keyboard video mouth switch and the ethernet nport 5110 that connects it to the cabinet were replaced and the system was returned to use in good working order.A search in the complaint database did not show any similar complaints.No further actions will be taken.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10
• 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: 8611375
• MDR Text Key: 145226447
• Report Number: 3003768277-2019-00039
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70