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

Model Number 722038

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It has been reported to philips that during an emergency procedure for a cerebral angiogram stroke intervention, a malfunction occurred because of which the procedure was aborted.No harm to the patient has been reported to philips.Philips has started an investigation for this complaint.

Event Description

It has been reported to philips that during an emergency procedure for a cerebral angiogram stroke intervention, a malfunction occurred because of which the procedure was aborted.Philips has started an investigation for this complaint.No harm to the patient has been reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.The patient involved was under general anesthesia.After the system stopped working, the patient was moved to another room where the procedure was successfully completed.No harm was reported.Philips has confirmed with the customer that the procedure outcome was as expected.Philips inspected the system on site and found that the cathlab with the philips allura x-ray system is located next to a cathlab with a toshiba/canon system.The toshiba/canon system is powered by an eaton uninterruptible power supply (ups), which is on the same hospital mains circuit as the philips allura x-ray system.The eaton ups is not connected to the philips cath lab.The incident occurred because the eaton ups had failing components that caused harmonic distortion back onto the hospital main power line, which disrupted the power to the philips x-ray system causing a failure due to which no x-ray was produced.An analysis of the logfiles of the philips x-ray system shows that there was no malfunction of the system.The ups was not delivered or maintained by philips.A third party service group solved the problem with the eaton ups.The philips allura x-ray system was tested and working according to specification.Based on the investigation results, philips has concluded that there was no malfunction of the philips system.Consequently, philips has closed this complaint 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: 9726280
• MDR Text Key: 191400683
• Report Number: 3003768277-2020-00011
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054226141
• UDI-Public: (01)00884838054226141
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1