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

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 03/29/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the l-arm rotation cover became detached.The cover was retained by its safety chain.The customer reseated the l-arm cover and returned the system to use.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the information collected, the planned coronary procedure was continued after the cover was reseated.A philips engineer inspected the system onsite and confirmed that the rubber blocks of the cover and the safety chain were in good state.The engineer tightened the fasteners that attach the cover and reseated the cover.The system was returned to use in good working order.Based on the available information, the l-arm cover likely detached because of a collision.

• 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: 14084395
• MDR Text Key: 289093568
• Report Number: 3003768277-2022-00158
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054189
• UDI-Public: 00884838054189
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• 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: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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