MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC. BRILLIANCE 10; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 72851

Device Problems Poor Quality Image (1408); Material Integrity Problem (2978)

Patient Problems Cancer (3262); Solid Tumour (4552)

Event Date 09/19/2019

Event Type  Death  

Event Description

I am the adult son of, and the executor of the estate of, a patient who passed away on (b)(6) 2020 due to complications from bladder cancer.An expert radiologist commissioned by the estate has concluded that a bladder tumor was missed in (b)(6) 2019.The failure to detect the tumor resulted in a delayed diagnosis of approximately eleven (11) months.The patient underwent a ct scan on a philips brilliance 10 ct scanner on (b)(6) 2019 at (b)(4) hospital, dobbs ferry pavilion in (b)(4).The expert radiologist has determined that the ct scan images were of such poor diagnostic quality that they prevented a determination of the extent to which the patient's tumor had invaded her bladder.In (b)(6) 2015, the patient received a total hip replacement containing parts that were made of a titanium alloy.The philips brilliance 10 ct scanner became obsolete in 2012, when a software filter, known as "metal artifact reduction for orthopedic implants," or "o-mar," which was designed to reduce or eliminate streaking artifacts caused by metallic implants, was introduced into the philips medical systems, inc.'s newer lines and models of ct scanners.The software filter was not an option on the philips brilliance 10 ct scanner that was, and continues to be, in use at (b)(4).The philips brilliance 10 ct scanner has been inspected irregularly since it was assembled in or around 2008-09.Inspections do not appear to have been carried out for the years 2010, 2018, and 2020.Inspection surveys for 2012, 2014, and 2016 show that the philips brilliance 10 ct scanner has been consistently rated as fully compliant with the assessment criteria, even after it became obsolete in 2012.The fda center for devices and radiological health ("cdrh"), the (b)(4) state department of health bureau of environmental radiation protection, and (b)(4), all appear not to have received a copy of the completed assembly report (form fda-2579) from the assembler.Finally, a certificate of need ("con") application does not appear to have been filed by (b)(4) for the philips brilliance 10 ct scanner prior to purchase.The impact of the failure to thoroughly inspect and upgrade (b)(4) philips brilliance 10 ct scanner is significant: for every delayed diagnosis or misdiagnosis that occurs due to the presence of a metallic implant that leads to streaking artifacts in a ct scan that is performed there, a repeat study must be performed elsewhere on more modern equipment, doubling the dose of radiation to which the patient is exposed.The test result is contradicted by expert opinion, which also determined that the ct scan images were of such poor diagnostic quality that they prevented a determination of the extent to which the patient's tumor had invaded her bladder.Fda safety report id# (b)(6).

Event Description

Additional information received from the reporter on 08/07/2023 for report number mw5110808.Things, that the absence of a metal artifact reduction filter in the software installed on the same ct scanner led, in part, to a near eleven-month delay in the diagnosis of decedent's bladder cancer, narrowing her treatment options and, ultimately, hastening her death.By letter, dated (b)(6) 2022, your office acknowledged receipt of the estate's voluntary mdr, assigning it access no.(b)(4).On (b)(6) 2022, philips medical systems nederland, b.V., fei 3002807880, submitted a mandatory mdr as a preliminary response to the estate's voluntary mdr.Initially, the mandatory mdr summarized the content of the estate's voluntary mdr.Next, the mandatory mdr acknowledged that the poor image quality produced by the philips brilliance 10 air at (b)(6) during a ct scan that decedent underwent on (b)(6) 2019 is a reportable event because it is alleged to have contributed to her death.Lastly, the mandatory mdr stated that the same event was under investigation.I write to inform your office of philips healthcare's subsequent response to the estate's voluntary mdr.While the estate is grateful to (b)(6) son for the information that she provided, it respectfully disagrees with her contention that the philips brilliance 10 air ct scanner at (b)(6) "worked as intended" for all patients when it was used to scan decedent in (b)(6) 2019.First, the same ct scanner fails to produce diagnostic­ quality images for patients that have metallic implants.Second, the philips brilliance 10 air ct scanner appears to be one configuration in a family of ct scanners that philips healthcare has been marketing without the appropriate clearances, in violation of the federal food, drug and cosmetic act of 1938 (the "fdca").When a ct scan is performed on a patient who has received a metallic implant, including, but not limited to, hip replacements, pacemakers, and tooth filings, the interaction between the metallic implant and the x-rays emitted by the ct scanner will cause streaking artifacts to appear in the final images produced by the ct scanner ("metal artifacts").Depending on the circumstances, the metal artifacts may partially, or completely, obscure the area of interest in a set of ct scan images.The specific question of how to best reduce or eliminate metal artifacts in ct scanning has been the subject of ongoing academic studies.Expressly building on the academic studies, metal artifact reduction filters have been researched, developed, and patented by the major manufacturers of ct scanners, including, philips healthcare.Indeed, metal artifact reduction filters are now a standard feature in ct scanner software.

• Brand Name: BRILLIANCE 10
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
• MDR Report Key: 15001626
• MDR Text Key: 295885186
• Report Number: MW5110808
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72851
• Patient Sequence Number: 1
• Treatment: ATENOLOL
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White