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

Model Number ALLURA XPER FD10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the allura xper fd10 system c-arm ceiling mounted cover fell down.It was later confirmed to have been the z-rotation movement cover which had come off.The system was in unknown use and no harm has been reported.The z-rotation chain was repaired and the cover secured to the device to return it back to functionality.Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in clinical use and the issue occurred during a planned vascular treatment.The philips field service engineer (fse) inspected the system onsite and confirmed that the c-arm ceiling mounted cover fell.The fse later confirmed that it was the z-rotation movement cover which came off.The fse also found that the customer had moved the l-arm to the foot end due to which the l-arm accidently got coiled with the ot light rode and got removed from the lock.The fse fixed the cover chain to resolve the issue.After the repair, 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: 17141955
• MDR Text Key: 317309577
• Report Number: 3003768277-2023-03668
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130842
• 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,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?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2013
• 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