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

Model Number 722003

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Field service engineer replaced pc host back, power supply, and the mother board the investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

Philips received a complaint where it was reported to philips that: during a surgery procedure the surgeon decided to stop, at that moment the system stopped working without any reason.The user tried to restart the system without success.The patient was not harmed but needed to come back to continue with the procedure the next day.

Manufacturer Narrative

Investigation by a philips field service engineer (fse) and our subject matter experts showed that the most likely cause of the issue was a defect of an empty pc box with backpannel.This empty pc box is meant to install all parts of the pc, such as printed circuit boards.A failure of an empty pc box causes the system to stop abruptly in such a way that no logging is available anymore.A search in our complaint database did not show any similar complaints in the past years.No structural issue was identified, and therefore no further actions will be taken.Replacement of the empty pc box solved the issue for this customer.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7036758
• MDR Text Key: 92505688
• Report Number: 3003768277-2017-00097
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 100