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 Problems Shielding Failure (1568); Detachment of Device or Device Component (2907)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the cover for the joint on the ceiling hung protector has dislodged.Philips has started an investigation of this complaint.Note: we have not completed our investigation of this event.We will file a follow-up report at the completion of this investigation.Internal cross reference: complaint pr# (b)(4).

Manufacturer Narrative

Philips has investigated this complaint.According to the information collected, the cover did not fall from the device.The cover of the suspension arm that holds the radiation shield was found to be misaligned, but was still attached to the suspension arm.The cover misaligned due to external force applied to the arm, potentially the suspension arm was hit by the allura c-arm.The philips engineer realigned and reattached the arm covers.After reattachment of the covers, the system was returned to use in good working order.As explained in the instructions for use: ¿during execution of both manual and motorized movements of the stand(s) or the table, the operator is responsible for the safety of patient, staff and equipment.The operator must avoid collisions in order to prevent serious injury to patient and staff or damage to the equipment.¿ the codes were updated based on the investigation outcome.Device problem code was corrected.

• 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: 15584819
• MDR Text Key: 301827683
• Report Number: 3003768277-2022-00484
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054196
• UDI-Public: 00884838054196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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