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

Model Number ALLURA XPER FD10

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the l-arm rotation cover is possibly loose and may fall off.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.It was reported to philips that the l-arm rotation cover is possibly loose and may fall off.As per the customer information, the customer was informed by mail that the allura system was not affected by the field change order.No work was performed by philips.No further information regarding the issue has been provided.The codes were updated based on the investigation outcome.

Manufacturer Narrative

Philips has performed a review of this event.The reported event is regarding a customer inquiry about the field safety corrective action (fsca) 2022-igt-bst-002.Customer has one device affected by fsca 2022-igt-bst-002.After receiving the field safety notice associated to this fsca, customer contacted philips to request implementation of the correction in a second device.Philips informed the customer that this second device for which they requested implementation of the correction is not affected by fsca 2022-igt-bst-002.There was no allegation of a product malfunction and there was no actual event.Based on this information, philips concludes that this event is not reportable.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18317044
• MDR Text Key: 330331265
• Report Number: 3003768277-2023-06924
• Device Sequence Number: 1
• Product Code: IZI
• 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,Followup,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?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/25/2024; 03/18/2024
• Supplement Dates FDA Received: 02/05/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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