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

Model Number 722010

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It was reported to philips that during a procedure on (b)(6) 2018 a patient went into cardiac arrest.This cardiac arrest was prior to an error message that appeared: ¿table movement only partially available".So this malfunction did not cause the cardiac arrest.The table did not lock and the customer performed a cardiopulmonary resuscitation.The customer finished the procedure successfully in another room on the same day.A new power supply was installed and the system is back in clinical use.

Manufacturer Narrative

Philips investigated this complaint.Philips checked the system and confirmed that the power supply of the table failed.The power supply was replaced and the system was put back in working order.Analysis of replacement rate for power supply did not show any negative trend.No further action will be taken.

• 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: 7471900
• MDR Text Key: 106979391
• Report Number: 3003768277-2018-00031
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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: 71 YR