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

Model Number 722010

Device Problem Loss of Power (1475)

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 the system stopped working during fluoroscopy.The system was not in clinical use at the time of this incident and no patient was in the room.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.A philips field service engineer (fse) went on site and performed trouble shooting of the system, at which time smoke started coming out of the converter.The converters are ul 94 certified, and therefore any possible fire will self-extinguish.The fse confirmed that the root cause of the issue is that the converter failed.The converter was replaced with a new converter which is much more robust against mains disturbances and will prevent early failure of the converter.The system was returned to use in good working order.Philips has opened an investigation as a follow up for the noted 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 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
• MDR Report Key: 9437504
• MDR Text Key: 181522322
• Report Number: 3003768277-2019-00100
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1