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

Model Number ALLURA XPER FD10/10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the ceiling mounted arm covering has come away from the system during clinical use and the customer is concerned about the infection risk.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The reported problem was further clarified by the user.According to the information collected, the system was not in clinical use and there was no risk of patient infection.Investigation revealed that a small piece of the ceiling mounted arm covering unclipped.A philips engineer resolved the issue by clipping the plastic piece back together and attaching a cable tie to the ceiling mounted cover to prevent it from unclipping.Philips evaluates this complaint as not reportable as no serious incident occurred and a serious injury is not likely to occur.Philips has concluded that the detachment of the small plastic part is most probably due to collision with other equipment.The instructions for use warns the user that the operator is responsible for the safety of patient, staff, and equipment during manual and motorized movements of the stand or table.Collisions should be avoided to prevent serious injury to patient and staff, or damage to the equipment.The ifu also includes a caution if a collision occurs involving any part of the system.If any equipment cover breaks or becomes detached, the user should finish the case, switch off the power and contact technical support.Codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 15377878
• MDR Text Key: 299851473
• Report Number: 3003768277-2022-00413
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054196
• UDI-Public: 00884838054196
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10/10
• Device Catalogue Number: 722027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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