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

Model Number ALLURA XPER FD20

Device Problems Fire (1245); Activation, Positioning or Separation Problem (2906)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the system wouldn't boot up.The system was not in clinical use.The ups was serviced by the provider and when it was turned on again, it is reported that sparks and fire came from the panel.No harm has been reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the system was not able to start.As a part of troubleshooting, the fse checked the panel, uninterruptible power supply (ups) logs and voltage measurement was checked.Fse examined the ups and no equipment problems were found.Fse restarted the system and there was a sparking fire from the panel.The fse suspected that the hospital technician had connected to the incorrect port which might have caused the spark.To resolve the issue, all the prerequisites for proper power on were checked.After ensuring the electrical component requirements, the system was restarted.After checking the prerequisites, component requirements and restarting the system, the system returned to use in good working order.The codes were updated based on the investigation outcome.Device problem code, evaluation method grid and conclusion were corrected.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 15813049
• MDR Text Key: 303789641
• Report Number: 3003768277-2022-01031
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K161563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• 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