MAUDE Adverse Event Report: ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD20 OR TABLE

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

It has been reported to philips that during treatment in the hybrid operating room, the operating table was set in motion without manipulation.No harm to the patient has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.A philips engineer inspected the system onsite and could not reproduce the reported problem.The control module that controls the table movements as well as the c-arm movements was inspected, and it was identified that the knob that controls the c-arm movements was faulty.This failure does not explain the problem reported by the customer.The control module was replaced after which the system was returned in good working order.To continue the investigation philips would require the replaced control module.Philips has completed a good faith effort to get additional information regarding the reported unintended movement and to confirm if the faulty control module was still available for analysis.The customer declined to provide the requested information.Based on available information philips cannot confirm the reported problem and cannot perform additional investigation.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• MDR Report Key: 11876263
• MDR Text Key: 252379554
• Report Number: 3003768277-2021-10019
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059085
• UDI-Public: 00884838059085
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• 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 FD20 OR TABLE
• Device Catalogue Number: 722023
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/12/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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: 57 YR