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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It has been reported to philips that the patient rolled off the table and the patient was harmed.Based on the limited information provided this initial report is submitted.Although no information was provided indicating the severity of the reported harm, philips is conservatively reporting this issue as a serious adverse event.Philips has requested additional information and has initiated an investigation.

Manufacturer Narrative

Philips has investigated the reported problem.Philips has completed a good faith effort to get further information regarding patient outcome and sequence of events of the reported problem.However, the customer has not provided any additional information.Initially, information was received that the patient sustained harm, but the extent of the harm is unknown.The customer initially contacted philips for additional patient restraints which have since been provided in the form of patient straps.According to the available information provided by the customer the patient was not secured to the table and rolled off.As no additional information is provided for investigation, philips is closing this complaint and this event will be included in the post market surveillance trend analysis.

• 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: 15127579
• MDR Text Key: 296843772
• Report Number: 3003768277-2022-00347
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059115
• UDI-Public: 00884838059115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 12/01/2022
• Date Device Manufactured: 09/07/2017
• 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