MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 OR TABLE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD20 OR TABLE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It has been reported to philips that part of the cover of the c-arc or x-ray protective shield on the allura xper fd20 or table system came off and not only fell almost on the user's head but also almost into the sterile field.This all happened during the ongoing surgery.No harm has been reported.Philips has stated an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the parts were falling, and user was endangered.As a part of troubleshooting process, fse identified that the mavig support arm of the lead protector was defective (fairing on the lower support arm fell off).Fse ordered the mavig end caps, ornamental hose and replaced.Fse stated that the covers were not replaced because the arm was bent.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: ALLURA XPER FD20 OR TABLE
• 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: 17125657
• MDR Text Key: 317309334
• Report Number: 3003768277-2023-03612
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130842
• 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

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 FD20 OR TABLE
• Device Catalogue Number: 722015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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