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

Model Number ALLURA XPER FD20/15

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  Injury  

Event Description

It has been reported to philips that during a planned non-emergency procedure, the user's finger got caught between the table and the lead protection shield.Hereby the user broke his/her finger.Philips has started an investigation for this complaint.

Event Description

Initial: it has been reported to philips that during a planned non-emergency procedure, the user's finger got caught between the table and the lead protection shield.Hereby the user broke his/her finger.Philips has started an investigation for this complaint.Follow up: philips has investigated this complaint.Based on photos of the situation provided to philips, the injury was caused when the technician placed his hand between the radiation shield and the tabletop and simultaneously moved the table.According to the instructions for use (4522 203 17232 chapter 3.6), 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.No malfunction of the system could be identified.

• 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
• MDR Report Key: 10649609
• MDR Text Key: 210425819
• Report Number: 3003768277-2020-01008
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059115
• UDI-Public: 00884838059115
• Combination Product (y/n): N
• PMA/PMN Number: K141979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20/15
• Device Catalogue Number: 722058
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/28/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 50