MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD20

Device Problem No Display/Image (1183)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

It has been reported to philips that during an emergency coronary stent placement procedure the system lost power.No patient harm has been reported.Philips has started an investigation for this complaint.

Event Description

Philips has confirmed with the customer that during an emergency coronary stent placement procedure the system shut down suddenly and would not start up again.The patient was transferred to another system where the procedure was completed.Philips has inspected the system on site and based on troubleshooting performed, determined that the main power distribution (mpd) control unit had failed.The analysis of the log files confirmed the occurrence of the reported issue.The mpd control unit was replaced after which the system was returned to use in good working order.Based on trending analysis there is no negative trend in the replacement rate for the mpd control units.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10718112
• MDR Text Key: 212508693
• Report Number: 3003768277-2020-01014
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

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: ALLURA XPER FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/29/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other