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 Problem Detachment of Device or Device Component (2907)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the mavig support arm holding the radiation shield became detached from the ceiling rail.The mavig support arm and the radiation shield fell down on the floor.Cleaning personnel was in the room when the issue occurred, but the person was not standing near the mavig arm.The system was not in clinical use and no harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Addtl narrative: philips has investigated this complaint.The mavig support arm is attached to the philips system through a bracket and this bracket is attached to the ceiling rail.Onsite inspection of the system confirmed that the bolts that attach the bracket to the ceiling rail loosened, causing the bracket with the mavig support arm to fall.The bracket was reattached to the rail using loctite and extra bolts.The system was returned to use in good working order.Corrected data: codes updated as per the investigation outcome.

• 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: 14450823
• MDR Text Key: 292961264
• Report Number: 3003768277-2022-00240
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059115
• UDI-Public: 00884838059115
• Combination Product (y/n): N
• Reporter Country Code: JM
• 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 FD20/15
• Device Catalogue Number: 722058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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