MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722035

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 the startup of the system, the operator noticed that the system displayed a geometry error message.The operator called the hospital engineer who noticed a strong burning smell coming from the technical room.After a few minutes, the smoke alarm went off and the fire brigade arrived.The fire brigade used a heat camera and located a hot spot in the cabinet in the technical room.Heat, smoke and burning smell were observed however no fire was found.The smell spread to the operating corridors on level 6 of the hospital, and the majority of all operating labs were disturbed by the incident.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.Philips has inspected the system on site and confirmed that a malfunction of the x-ray system¿s power distribution unit (pdu) caused it to short circuit, leading to the burning smell coming from the technical room.Philips has investigated the pdu and determined that there were irregularities in the winding of the transformer in the pdu which caused a short circuit philips has registered a product defect with the supplier as a follow-up to the noted complaint.The pdu was replaced after which the system was returned to use in good working order.No similar complaints have been identified.Based on trending analysis there is no negative trend replacement rate for the pdu.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 OR TABLE
• 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: 9597876
• MDR Text Key: 179725594
• Report Number: 3003768277-2020-00003
• Device Sequence Number: 1
• Product Code: OWB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722035
• Device Catalogue Number: 722035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1