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

Model Number 722003

Device Problem Component Missing (2306)

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

It was reported to philips that during a cardiac catherization procedure, cine was not available.The patient had a sheath inserted which was taken out.The procedure was aborted and rescheduled.No harm to the patient has been reported to philips.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.The log files were analyzed.It was confirmed that when the image storage board fails cine is not available because cine images need to be automatically saved to the image storage board.However, the fluoroscopy is still available since fluoroscopy images are not automatically saved.The image storage board was replaced after which the system was returned to use in good working order.Based on trending analysis there is no exceptional replacement rate for the image storage boards.No harm has been reported.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: 8802010
• MDR Text Key: 151617618
• Report Number: 3003768277-2019-00056
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 06/20/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 83