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

Model Number ALLURA XPER FD10

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2022

Event Type  Injury  

Event Description

It has been reported to philips that the cover of the ceiling suspended light had been damaged the previous week and therefore removed.The decision had been made by the customer to continue using the light.During a planned clinical intervention, the light was moved over the patient.White flakes and dust particles that had fallen from inside the light assembly were then observed on the blunt scissors and on the table immediately surrounding them.The area of the table was covered to maintain a sterile field and the equipment was re-sterilized.The wound was irrigated and the procedure was completed with additional infection prevention measures.Additional antibiotics were prescribed.No harm to the patient has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated the reported event.According to the information collected, during a previous procedure, the dispersion lens (cover) of the examination light had been damaged after a collision with a patient board while transferring a patient off the table.The reported event occurred from the user's decision to keep using the light without a dispersion lens (cover).It is the user¿s responsibility to not continue using defective equipment.As per instructions for use: ¿do not use the system if you suspect that any part of the equipment is defective.Operation of the system in a defective state could lead to fatal or serious injury.¿ a philips service engineer inspected the system on site and found that the dispersion lens of the examination light was missing, and the halogen bulb was defective.The philips engineer replaced the dispersion lens and the halogen bulb and the examination light was returned to use in good working order.Corrected data: coding updated based on investigation outcome.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15355303
• MDR Text Key: 299272494
• Report Number: 3003768277-2022-00401
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/05/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2005
• 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