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

Model Number ALLURA XPER FD10/10

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

Event Type  Injury  

Event Description

It has been reported to philips that the geometry movements of the allura xper fd10/10 system were not available during an emergency cardiac procedure after the user pressed one of the e-stop buttons.A clinical staff member indicated that the patient has probably been harmed, however no information regarding an actual harm has been provided.Philips has started an investigation of this complaint.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18019714
• MDR Text Key: 326676652
• Report Number: 3003768277-2023-05878
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059047
• UDI-Public: 00884838059047
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10/10
• Device Catalogue Number: 722011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/27/2023
• Date Device Manufactured: 06/15/2011
• 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 Outcome(s): Other