MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AEMERICAS CORPORATION SYNAPSE RADIOLOGY PACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number	890000004
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint number (b)(4).
Event or Problem Description
On (b)(6), 2023, fujifilm healthcare americas corporation became aware of a product problem involving synapse software.It was reported that the site upgraded from v5.7 to v.7.3 last month.In v5.7, when images were annotated in vrad and sent to synapse, the image size (mg only) was maintained since the upgrade to v7.3.002.The images initially displayed the expected size but if they scroll through the images, the size shrinks to very small.The site has tried to adjust the different zoom factors and using just a synapse default reading protocol with no luck.No additional information provided.
Additional Manufacturer Narrative
Ref comp#(b)(4).It was reported that the images initially display the expected size but if they scroll through the images the size shrinks too very small.This was investigated and as part of the investigation it was found that if a user does measurements on these images the measurements will be incorrect.The issue as reported initially would be a workflow issue with minor severity.However, the measurement issue is a major severity.The fmea for the measurement issue is: 9018-00: image management features (print, measurement, overlay, annotation, etc.) providing incorrect data - software defect.Technical investigation: the code inadvertently uses the pixel spacing of the breast tomo series on the secondary capture image.Secondary capture images typically do not have pixel spacing as it was for the case reported.Based on the modality vendor mg secondary capture images may contain pixel spacing and in such case this issue does not exist.Measurements should not be performed without a valid pixel spacing.In the reported case the software application applied the incorrect pixel spacing to the secondary capture image and as a result the measurement functionality can be performed by the end user that produces incorrect measurements.This needs to be corrected.Clinical assessment/impact: the clinical review conducted confirms the technical investigation.A correction is needed.If the radiologist relies on the measurement provided, he/she may misdiagnose.The radiologists do know that images without pixel spacing need to be calibrated and in some cases can identify such images by visual clues such as burned in annotations.However, this may not always be obvious and in some cases the radiologists will not know that the image in question has no pixel spacing unless measurements are not shown or are prevented via the user interface.There is a risk of using incorrect measurements as part of the diagnosis and potentially misdiagnosing the patient.Escalation number: (b)(4).Escalated to ns3 bug number (b)(4).Troubleshooting: fujifilm service has the images in box.Loaded into vm for 5.7 and also 7.3.000 ( site is on 7.3.100) when the study loads in a system mammo protocols the images look ok.There are secondary captures and in the series that has 2 images, if scroll to the second image and scroll back in v7 the image is very tiny.Service has tried to play with the zoom to breast bounds, created new protocols- same behavior.If open up the image and scroll through- the images functions as expected, if u double click on the thumbnail and load in the series viewer it behaves as expected as well.This is a change from what happens in v5.7 ( video included).
Additional Manufacturer Narrative
Ref comp (b)(4).The second supplemental mdr is being submitted in regard to fda's email to hcus about udi correction in refence with gudid.Followings are the corrected sections in the report.D1, g1.
Additional Manufacturer Narrative
Ref comp #(b)(4).The third supplemental mdr is being submitted in regard to correct manufacturer contact information g1.

• Brand Name: SYNAPSE RADIOLOGY PACS
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): FUJIFILM HEALTHCARE AEMERICAS CORPORATION; 79 tw alexander drive; building 4501 suit 300; durham NC 27709
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 79 tw alexander dr.; building 4501, suite 300; durham NC 27709
• Manufacturer Contact: randy vader ; 79 tw alexander dr.; building 4501, suite 300; durham, NC 27709 ; 3603566821
• MDR Report Key: 18377215
• Report Number: 3004972322-2023-00003
• Device Sequence Number: 15405305
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0703000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 890000004
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023; Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/14/2024; 09/20/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown