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

Model Number ALLURA XPER FD20

Device Problems Positioning Failure (1158); Unintended System Motion (1430)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 02/02/2022

Event Type  Injury  

Event Description

It has been reported to philips that while transferring a patient from the table to the bed after completion of a vascular procedure, the lateral table brake did not hold and the tabletop moved.The patient fell to the floor.The impact to the patient is unknown.Philips has completed a good faith effort to get further information on the reported incident and the patient outcome.The only information received is that the patient¿s weight was more than 300 lbs.Philips has started an investigation of this complaint.

Manufacturer Narrative

Additional narrative: a philips service engineer inspected the system onsite.The tabletop¿s lateral brake function was tested, and measurements showed that the brake force was within specification.Because of the event reported by the customer, the lateral brake and brake strip were replaced, and the brake force was increased.Additionally, a va brake was installed.This brake will ensure that the table will not free float in case there is no power to the table.Philips concludes that there was no malfunction of the system.Corrected data: event date has been updated and codes have been updated.

• 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: 13648279
• MDR Text Key: 286446158
• Report Number: 3003768277-2022-00086
• 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: 02/03/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• 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
• Patient Weight: 136 KG