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

Model Number ALLURA XPER FD10

Device Problems No Device Output (1435); Radiation Output Failure (4027)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 12/07/2022

Event Type  Death  

Event Description

It has been reported to philips that the allura system stopped functioning during a catheterization procedure and the patient passed away.Philips has started an investigation of this complaint.A follow up report will be submitted when further information is available.

Manufacturer Narrative

Additional narrative: as part of the complaint handling investigation process, philips has undertaken good faith efforts to ascertain clinical details of this event from the hospital.However, based on the follow-up communications with the hospital, there was limited clinical information provided.Any additional information regarding the clinical aspects is primarily from third parties and media reports and could neither be verified nor confirmed by philips.In summary: a 78-year-old patient was hospitalized on (b)(6), 2022, and was scheduled for a planned catheterization procedure on (b)(6), 2022.During the procedure, a number of blockages in the lad artery were successfully opened.During an attempt to treat the lt main/lad area, the allura system stopped functioning and a restart of the system did not restore the functionality of the allura system.In parallel, the patient¿s hemodynamics deteriorated, and cpr was initiated.It was indicated that patient monitoring abilities were limited.During resuscitation, the patient was transferred to another (non-philips) catheterization lab.Imaging in the other catheterization lab did not demonstrate any blockage in the arteries, but damage of the heart mechanical function was observed, and the patient passed away.The extent of the lt main/ lad treatment attempts and the heart¿s mechanical function and / or deterioration is unknown to philips.The allura system was installed on (b)(6), 2013, at (b)(6) hospital, a (b)(6) hospital with the maintenance service of the allura system being performed by clalit engineering, a (b)(6) subsidiary.From (b)(6), 2022, philips engineers evaluated and investigated the system onsite, collected log files, gathered photos, and drafted a timeline of the technical aspects of the event based on conversations with stakeholders.Evaluation of the trace files (from (b)(6), 2022) which contain advanced troubleshooting/investigative data was not possible due to file corruption.During the onsite evaluation of the allura system, philips engineers identified that a host pc may have contributed to the allura system¿s functionality, and the host pc and video card involved in the event were returned to philips for analysis (as further detailed below).In addition, during philips¿ onsite evaluation, it was observed that the third-party hemodynamics monitor was powered via the allura system instead of the mains power of the hospital, resulting in the hemodynamics monitor loss of power during allura restart.This power connection may have contributed to the reported limited availability of monitoring capabilities during the event.Philips analyzed the collected log files from the host pc dating from (b)(6) 2022.- log files showed that the ¿original host pc¿ was replaced with a ¿replacement host pc¿ on (b)(6) 2022.When the replacement host pc was not functioning, its hardware was reconfigured at the hospital using the dimms (memory module) and video card taken from the original host pc, creating a ¿reconfigured host pc¿.- the reconfigured host pc initially appeared to be functioning with these swapped parts.However, one log file registered a corruption of the master file table, which is where the directory structure of the operating system (¿os¿) disk is stored (on the os disk).Continued use of a disk in this state can lead to further corruption of the contents of the disk.- the following days, the system was used for clinical procedures.The message related to the master file table corruption was still visible in the log file.- on (b)(6) 2022, daily system checks were performed by a hospital x-ray technician beginning at 7:10 am.The technician noted that the fluoroscopy functionality was limited, and a windows blue screen appeared on the data monitor in the control room.The log file confirms that the system unexpectedly stopped functioning at approximately 7:30 am as indicated by the windows blue screen.The technician captured a photo of the windows blue screen that showed an error message, which indicated that the motherboard and os disk were not communicating.The technician restarted the system and cleared the system for clinical use.At 8:39 am, the reported patient catheterization event was started, being the first procedure of the day.At 9:32 am, a general hardware error was prompted to the user on the data monitor, indicating that there was a flawed connection to the os disk, and the system stopped functioning.As previously described in the reported event, restart of the system was not successful.Philips performed a physical inspection of the reconfigured host pc at its lab.It was confirmed that the video card and dimms (memory module) from the original host pc were swapped into the replacement host pc.Inspection of the video card that was initially in the replacement host pc confirmed that it was not functional.When a video card is not functional, images will not be properly displayed on the screen.Further analysis of the reconfigured host pc confirmed the presence of a disk bay error, interrupting the communication between the motherboard and os disk.Based on the analysis performed, philips concludes that: - on (b)(6) 2022, when it was identified that the replacement host pc was not functioning, service procedure indicated for the replacement host pc to be returned and a new host pc to be ordered.Instead, the replacement host pc was reconfigured using a combination of parts from the original host pc as well as the replacement host pc; thereby, creating the reconfigured host pc, an altered computer, that was then connected to the system.Philips service instructions do not include instructions for hardware replacement of the pc, as the philips pc repair operations take place through a centralized stream to ensure the pc and any repairs thereto are appropriately tested in a non-clinical environment prior to release for use at customer site(s).Philips¿ repair manual for the image processor and host pc states: ¿it is not permitted to replace or add non-released items to the configuration during installation or service.¿.- on (b)(6) 2022, following the blue screen error message (generated from windows os) that occurred as part of the x-ray technician¿s daily check, it would have been appropriate to initiate a service call prior to returning the system to clinical use considering the repairs the system underwent in the previous days.Per the instructions for use, ¿if any part of the allura xper fd series is known (or suspected) to be defective or wrongly adjusted, do not use the allura xper fd series until a repair has been made.Operation of the allura xper fd series with defective or wrongly adjusted components could expose the user or the patient to radiation or other safety hazards.This could lead to fatal or other serious personal injury, or to clinical misdiagnosis/clinical mistreatment.¿.- during the event on (b)(6) 2022, the system stopped functioning following the interruption of the communication between the motherboard and os disk caused by a disk bay error.- based on the limited clinical information available, philips cannot establish if the non-functioning of the system contributed to the patient outcome.The allura system currently is not in clinical use as the hospital decided to dismantle the system, and it has been placed in storage.------------------- corrected data: codes have been updated as per the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15950212
• MDR Text Key: 305161533
• Report Number: 3003768277-2022-01440
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: 505
• 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 FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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: 78 YR
• Patient Sex: Male