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

Model Number ALLURA XPER FD20 BIPLANE

Device Problem Structural Problem (2506)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

It has been reported to philips that geometry movements were unavailable.The patient was on the table and had to be moved to another system, which delayed the procedure.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated the reported problem.A philips service engineer inspected the system and performed functional testing on-site.The reported problem was confirmed and upon investigation, it was determined that the bodyguard sensor was defective.The bodyguard tube cover and the sensor were replaced the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15973864
• MDR Text Key: 305637260
• Report Number: 3003768277-2022-01511
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• 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 BIPLANE
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2010
• 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