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

Model Number ALLURA XPER FD20

Device Problems Unintended System Motion (1430); Device Dislodged or Dislocated (2923)

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

Event Date 02/24/2021

Event Type  malfunction  

Event Description

It has been reported to philips that while transferring the patient the table pivoted.No harm to the patient has been reported.Philips has started the investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the information collected, the table pivoted when the patient was being moved from the patient bed to the ad5 table.To place the patient on the table, the staff first lowered the patient to the floor and then moved the patient to the ad5 table.A philips engineer inspected the system onsite and identified that there was rust on the table pivot which resulted in insufficient resistance of the pivot.The rust was cleaned, damaged components were replaced and the tension of the pivot was adjusted to specifications.After this, the system was returned to use in good working order.

• 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: 11481271
• MDR Text Key: 239743362
• Report Number: 3003768277-2021-10002
• 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: 03/15/2021
• 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: 02/24/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 117