MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD20

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bruise/Contusion (1754)

Event Date 04/23/2021

Event Type  malfunction  

Event Description

It has been reported to philips that while a patient was recovering from anesthesia, the table pivoted and the patient fell off the table.The patient sustained a bruise around the left eye.Philips has started an investigation of this complaint.

Manufacturer Narrative

Corrected data: the manufacturing date is updated to 7 jun 2007.This system is a refurbished system.The original manufacture date of the system was in 2007.Addtl narrative: philips has investigated this complaint and found that while recovering from anesthesia, a patient (male 340 lbs.) shifted the upper body, causing the table to pivot.The patient fell to the floor, resulting in a bruise to the upper left eye area of the face.A head ct was performed and additional wound care was provided.No further medical treatment was required.On inspection, the philips engineer found that the ad5 table friction threshold was too low, requiring less force to pivot the table.The pivot friction was brought up to specification, and as a precaution the pivot brake assy and friction pin were replaced.The system was returned to use in good working order.

Event Description

It has been reported to philips that while a patient was recovering from anesthesia, the table pivoted and the patient fell off the table.The patient sustained a bruise around the left eye.Philips has started an investigation of this complaint.

• Brand Name: ALLURA XPER FD20
• 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
• MDR Report Key: 11848364
• MDR Text Key: 251413281
• Report Number: 3003768277-2021-10016
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 722006
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/23/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 154