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

Model Number ALLURA XPER FD10

Device Problems Device Emits Odor (1425); Smoking (1585); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Patient (pt) on the table for a pvc (premature ventricular contractions) ablation.During the middle of the case, the x-ray system quit working and an electrical burnt smell began coming from the electrical room.Smoke was also noticed in the electrical room and scrub room.Facilities and phillips called for the smell and smoke.Procedure stopped for patient safety concerns.Patient was moved back to the stretcher and sheaths were pulled in the ep (electrophysiology) recovery area.Pt case aborted prior to completion due to x-ray system failure.(as provider was using stereotaxis system and did not want to proceed with a manual approach, procedure was aborted rather than moved to the other lab where x-ray still worked.) the issue occurred in the equipment room, which is not routinely monitored by staff.When the x-ray equipment failure happened, the staff entered the equipment room and there was no fire, flames, or smoke.However, there was a "burnt smell" and the room appeared "hazy" per staff.Facilities was called at time of incident with no resolution as it was specialized equipment.Philips notified within 20 minutes of event occurring.Fse (field service engineer) on site the next day to assess equipment issue.Determined a "high voltage converter" had failed and that both had to be replaced at the same time.Parts were ordered and installed the following day.Downtime for the room was 2 days.Provider spoke to patient and family regarding the incident.Manufacturer response for 722010,allura xper fd10, phillips (per site reporter).No follow information to note at this time.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; 3721 valley centre drive, suite 500; san diego CA 92130
• MDR Report Key: 13590814
• MDR Text Key: 286054481
• Report Number: 13590814
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2022,02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Race: White