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

Model Number ALLURA XPER FD20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

It was reported to philips that l-arm rotation cover came loose.No harm to patient or user has been reported to philips.Philips has started an investigation of this complaint.

Event Description

Initial: it was reported to philips that l-arm rotation cover came loose.No harm to patient or user has been reported to philips.Philips has started an investigation of this complaint.Follow up: philips has investigated this complaint.The system was not in clinical use when the reported problem occurred.Philips has confirmed that only the corner of the l-arm cover was loose and it was not fully detached.Philips replaced the l-arm cover and the system was returned to use in good working order.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10867895
• MDR Text Key: 217099933
• Report Number: 3003768277-2020-01028
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/02/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1