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

Model Number ALLURA XPER FD20

Device Problems Loss of Data (2903); Radiation Output Failure (4027)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2022

Event Type  Death  

Event Description

It has been reported to philips that during an emergency procedure, the system was not able to store images.The system prompted the user messages "write problem.Images possibly lost" and "exposure not possible.Image disk full".The customer performed a warm restart of the allura system and recreated image disk storage, but the issue was not resolved.The patient was moved to another room.During the patient transfer, the patient passed away.Philips has started an investigation of this complaint.

Manufacturer Narrative

Addtl narrative: according to the additional information collected from the radiologist at the (b)(6) hospital, the patient was treated for a splenic aneurysm that was actively bleeding.During the procedure, the allura system stopped functioning, exposure was no longer possible, and a warm restart did not resolve the issue.The patient was moved to a hybrid operating room.During transport the patient¿s condition deteriorated and resuscitation was started.The resuscitation was not successful, and the patient passed away a few minutes after arrival at the hybrid operating room.Patient care was provided by an intensivist during the procedure and transport.A philips service engineer inspected the system onsite and analyzed the log file.The log file showed image disk errors for the image processing pc (ippc).As a result, exposure was not possible, however fluoroscopy was still available.The customer confirmed that exposure was required to complete the procedure, therefore the patient was moved to another room.Log file analysis also confirmed that a warm restart of the allura system did not resolve the issue.The ippc has been returned for analysis and investigation confirmed a failure of the image disk bay in the ippc.--------- corrected data: codes are updated as per the investigation outcome and patient data is updated.

• 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
• 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: 15542816
• MDR Text Key: 301168015
• Report Number: 3003768277-2022-00456
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2012
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG