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

Model Number ALLURA XPER FD20 BIPLANE

Device Problem Radiation Output Failure (4027)

Patient Problems Brain Injury (2219); Insufficient Information (4580)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It has been reported to philips that during an emergency procedure for stroke treatment the wired footswitch was not working.This resulted in a delay of care of approximately 20-25 minutes.The patient was already at the end of a 6 hour window for stroke care when the system stopped functioning.At that time, no other exam room was available to transfer the patient to and the patient's symptoms exacerbated.Philips has started an investigation for this complaint.

Manufacturer Narrative

Addtl narrative: philips has investigated this complaint.According to the additional information collected, the customer was performing a thrombectomy procedure for a middle cerebral artery (mca) stroke when the wired footswitch stopped working.Restarting the system and unplugging the footswitch did not solve the issue.As there was minimal change in the patient¿s condition, initiation of treatment was at the end of the 6 hour window and no interventional x-ray system was available, the decision was made to not complete the procedure.Patient symptoms progressed over the next 24 hours and a large mca stroke was diagnosed.The philips engineer inspected the system on-site and indicated that the issue was likely caused by an issue with the footswitch cable.The complete footswitch was replaced, which resolved the issue.The wired footswitch was scrapped and not available for further analysis.The exact root cause of the failure could therefore not be confirmed ---.Corrected data: codes were updated.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHI
• 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: 13733412
• MDR Text Key: 287007365
• Report Number: 3003768277-2022-00108
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 BIPLANE
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2011
• 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