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

Model Number ALLURA XPER FD10

Device Problems Entrapment of Device (1212); Insufficient Information (3190)

Patient Problem Crushing Injury (1797)

Event Date 08/04/2022

Event Type  Injury  

Event Description

It has been reported to philips that while moving the table down to position the patient, the user's foot became stuck between the table cover and the floor.The user sustained a crush injury of the left forefoot.The user received first aid treatment (x-ray, ointment bandage and immobilization).Philips has started an investigation for this complaint.

Manufacturer Narrative

Addtl narrative: philips has investigated the complaint.According to the additional information collected, the user did not sustain a serious injury on the forefoot.The occupational physician advised forefoot immobilization with a forefoot relief shoe.The user has returned to work and currently is wearing normal shoes.A philips engineer inspected the system onsite and performed system tests.The system worked as per specification; no malfunction was identified.Philips evaluates this complaint as not reportable as no serious incident occurred and a serious injury is not likely to occur.Philips confirmed that there was no product malfunction and the device worked as specified.As per the instructions for use ¿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.¿ corrected data: adverse event/product problem has been updated to product problem as per the additional information collected, the user did not sustain a serious injury on the forefoot.Codes were 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: 15248584
• MDR Text Key: 298118687
• Report Number: 3003768277-2022-00378
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130638
• 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

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• 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
• Patient Outcome(s): Other