MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 BIPLANE (FD20/20); INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722038

Device Problems Break (1069); Device Fell (4014)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported to philips that during a neurovascular procedure where it was planned to use 3d rotational scans, the cable hose carrier cover of the c-arm broke and fell off.The procedure was successfully completed without performing any 3d rotational scans.No harm has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed with the customer that the procedure was completed successfully using 2d imaging in the absence of 3d rotational scans.Philips has completed a good faith effort to get further information on the reported incident and the patient outcome.However, the customer has not provided the requested information due to patient privacy.The customer did not request service from philips for this incident and has instead chosen to replace the cable hose carrier c-arc themselves.No further issues has been reported.Philips has analyzed the images of the broken cable hose carrier c-arc and concluded that the likely cause for such a breakage is collision.However, it could not be confirmed that a collision occurred.Based on trending analysis there is no negative trend in similar complaints.Based on trending analysis there is no negative trend with regard to replacements of the cable hose carrier c-arc.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 BIPLANE (FD20/20)
• 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: 10046546
• MDR Text Key: 191401549
• Report Number: 3003768277-2020-00021
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141979
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722038
• Device Catalogue Number: 722038
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1