MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problem Failure to Advance (2524)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It has been reported that the c-arm does not move.The system was in clinical use at the time of the event.No harm to the patient has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information provided, the system was not in clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirmed intermittent problem with geometry pc.Unable to communicate with geo ipc.Sid is unknown and no movement unavailable.Review of the system log file showed intermittent problem with geometry pc.Fse replaced new ipc geo computer, installed software and reloaded software.The system has been returned to use in good working order.The codes were updated based on the investigation outcome.Health impact code was corrected.

• Brand Name: ALLURA XPER FD10
• 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: 16032200
• MDR Text Key: 306077455
• Report Number: 3003768277-2022-01747
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• 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: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2009
• 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