MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problems Smoking (1585); Radiation Output Failure (4027)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

It has been reported to philips that during a premature ventricular contractions ablation (pvc) procedure, x-ray stopped working and a burning smell was coming from the equipment room.The procedure was stopped, the patient was moved back on the stretcher and into the ep recovery area where the sheaths were pulled out.No harm to the patient has been reported.When the staff entered the equipment room there was no fire, flames or smoke.However, there was a burning smell and the room appeared ¿hazy¿.Philips has started an investigation of this complaint.

Event Description

Philips confirmed the reported issue.Investigation showed that the converter 8e velara shorted internally.The converter showed smoke residue and smelled burned.Both converters were replaced which solved the issue on site.The defective converters were returned but it is unknown what happened to the returned parts.However, they were not available for further analysis.Therefore, technical part investigation was not possible.

Manufacturer Narrative

A philips service engineer inspected the system onsite and confirmed the reported issue.Investigation showed that the converter of the x-ray generator shorted internally.The converter showed smoke residue and smelled burned.The engineer replaced both converters and returned the system to use in good working order.Corrected data: codes are updated as per the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13720685
• MDR Text Key: 286930717
• Report Number: 3003768277-2022-00102
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: ALLURA XPER FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2012
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 97 KG