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

Model Number ALLURA XPER FD10

Device Problem No Device Output (1435)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported to philips that the emergency stop was activated and could not be dis-armed.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information received, it was unknown if the issue was identified while the system was in clinical use, but no patient or user harm was reported to philips.A philips remote service engineer (rse) inspected the system remotely and confirmed the issue.Troubleshooting by the rse and log file analysis confirmed an issue with the emergency stop button on the system's geometry module.As part of the troubleshooting, the rse advised the customer to ensure that the geometry module did not have any damaged, broken, or loose cabling or connectors.After troubleshooting, the issue did not reoccur, and the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method codes were corrected.

• 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: 16120805
• MDR Text Key: 306936286
• Report Number: 3003768277-2023-00119
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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 FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2011
• 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