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

Model Number ALLURA XPER FD20

Device Problem Unintended System Motion (1430)

Patient Problem Fall (1848)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the lateral/transverse table locks were not holding while transferring the patient from the allura system to the gurney and the patient fell to the floor.As per the available information, due to the fall the patient required x-ray imaging and a ct scan which showed no harm.The patient was discharged on the same day.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated the reported problem.Onsite inspection by a philips service engineer showed that the pan handle was sticking.It cannot be confirmed if the sticky pan handle caused the tabletop to move during patient transfer, the customer mentioned that the table brakes were locked.Analysis of the logfile did not show any system malfunction.As it could not be confirmed what caused the tabletop to move, the philips service engineer installed as a precautionary measure, a double lateral table brake to increase the brake force and replaced the pan handle.

• Brand Name: ALLURA XPER FD
• 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: 13599670
• MDR Text Key: 286949110
• Report Number: 3003768277-2022-00076
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130842
• 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 FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2010
• 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 Sex: Female