MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It has been reported to philips that while transferring the patient onto the table, the table pivot brake didn't hold.The patient fell to the floor from the table.No harm has been reported to philips.Philips has attempted to obtain further information on reported incident and the patient outcome.Philips has started an investigation of this complaint.

Manufacturer Narrative

Add mfr narr.Philips has investigated the reported problem.The customer confirmed that the patient did not sustain any harm or injury from the fall.This was confirmed with a ct scan.A philips service engineer inspected the system on site and identified that the pivot brake was incorrectly installed, causing the pivot brake to malfunction.The customer indicated that the pivot brake was recently replaced by a third party.As per instructions for use (4522 203 17232 chapter 8.2 and 8.3), the responsible organization of the equipment is responsible for ensuring that preventive maintenance is performed.Additionally, daily user checks should be carried out to ensure correct functioning of the brakes of the system.The philips engineer adjusted the pivot magnet and recalibrated the pivot brake in accordance with the specifications and the system was returned to use in good working order.Corr data coding updated based on investigation outcome.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 14494974
• MDR Text Key: 292584865
• Report Number: 3003768277-2022-00250
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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