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

Model Number ALLURA XPER FD20/15

Device Problems Data Problem (3196); Radiation Output Failure (4027)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It has been reported to philips that x-ray was not possible and the system showed a user message indicating that the image disk was full.The ongoing patient procedure was delayed 180 minutes.To date, no further information was received.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated the complaint.As per information provided by the customer, during a diagnostic procedure, the user received an error message indicating that the image disk was full and no x-ray was possible.The procedure was aborted and the patient was moved to another room with a delay of less than 20 minutes.The patient was not on the table during 180 minutes, the time it took to resolve the issue with the image disk and no patient harm was reported.Analysis of the system log file confirmed a corruption of the database.To resolve the issue, a philips field service engineer inspected the system onsite, corrected the corrupted database and returned the system to use in good working order.The root cause of the issue remains unknown.The most probable causes of the corrupted database are a previous unexpected shutdown of the system or imaging processing-pc disk errors.Codes were updated based on the investigation outcome.

• 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: 15137352
• MDR Text Key: 296974770
• Report Number: 3003768277-2022-00351
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059115
• UDI-Public: 00884838059115
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K162859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20/15
• Device Catalogue Number: 722058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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