MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; 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 08/16/2023

Event Type  malfunction  

Event Description

It has been reported to philips that a part of the marvig lighting/joint fell off and landed on the patient.The issue was found during clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) discussed with the customer and found that the cover was defective and fell on the customer due to which the customer might have been injured but no impact to the patient wa reported.On same day another another case was reported in servicemax 0122141690.It covers the same issue and the resolution in which the geo module wp kit was replaced.After which the cover issue was resolved.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Health impact code was corrected.

Manufacturer Narrative

Philips has investigated this complaint.It was reported that a cover from a joint on the mavig lighting arm came loose and fell down, coming into contact with the patient.The procedure was completed as planned, and there was no reported harm to the patient or user.A philips field service engineer (fse) inspected the system and identified that the covers of the mavig lighting arm were defective and required replacement.A quote was provided for the repair which was not accepted by the customer.The codes were updated based on the investigation outcome.

• 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: 17659971
• MDR Text Key: 322377728
• Report Number: 3003768277-2023-04729
• 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: 08/16/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 04/02/2024
• Supplement Dates FDA Received: 01/02/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2009
• 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