MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722006

Device Problem Break (1069)

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

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

Philips has received through the food and drug administration medwatch program a voluntary event report submitted by (b)(6) medical center (report number mw5091863).In this report, it was reported: hard drive on cardiac cathlab crashed resulting in images obtained during study to be deleted and unable to be recovered.The customer reported this event as a serious injury by the above mentioned voluntary event report, philips did not receive information or regarding the nature of the serious injury from the customer.No harm to the patient has been reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed that with the customer that no patient or user harm occurred.The procedure was completed successfully.Philips inspected the system on-site and replaced the hard disk after which the system was returned to use in good working order.Philips concludes that a defective hard disk was the most likely cause of the reported incident.Log files for the date of the procedure were no longer available on the system, so further analysis to determine the cause of the hard disk failure could not be performed.Consequently, philips has closed this complaint.The initial report was submitted as an adverse event and product problem, after consultation with the customer it was only a product problem.Therefore section b1 has been corrected accordingly into product problem only.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 FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9660996
• MDR Text Key: 177553939
• Report Number: 3003768277-2020-00007
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5091863
• Patient Sequence Number: 1
• Patient Outcome(s): Other