MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722027

Device Problem Device Emits Odor (1425)

Patient Problem No Code Available (3191)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Philips received a complaint from the customer in which it was stated that when the procedure had just begun with arterial and venous access obtained they aborted the procedure due to a strong smell of burning plastic.As a result of the event the patient sustained a vascular complication that occurred as a result of re accessing the patient the following day due to aborting the procedure the previous day.

Manufacturer Narrative

A philips service engineer checked the system and found that the coils of the anode drive unit (adu) located in the certeray generation overheated.The adu was replaced by an improved version.Analysis of the adu showed that the adu was overheated but it did not trigger the safety chain that is located near the sides of the coils.This means that an ambient temperature of 105 degrees celsius was not reached.Philips had initiated a correction on the field due to an increase in the failure rate of the adu of certeray x-ray generators in regions with mains voltage of 480v.Philips will reclassify the field correction initiated and report it through the appropriate channels for actions.This current voltage may lead to saturation and overheating of the coils that protect the igbts (insulated gate bipolar transistor) of the adu.Overheating will make the coils lose their protective function and voltage peaks can damage the igbts leading to a loss of function of the adu.The overheating will also generate a peculiar smell that may be noticed and in some instances before the igbts actually break down.The noted smell is caused by tin plated wires contain polyurethane as lacquer insulation.This wire is according to (b)(4) and has been tested by the manufacturer in accordance with (b)(4).

• Brand Name: ALLURA XPER FD10/10
• 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
• 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: 6841378
• MDR Text Key: 84634097
• Report Number: 3003768277-2017-00079
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722027
• Device Catalogue Number: 722027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86