MAUDE Adverse Event Report: CHANGE HEALTHCARE CANADA COMPANY CHANGE HEALTHCARE STRATUS IMAGING PACS

Model Number	1.4
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880); Data Problem (3196); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Under certain circumstances, information from hl7 messages received by the stratus pacs/ imaging share system have been incorrectly associated with another patient's study which may result in the following potential scenarios: 1.A subset of patient study metadata (patient name, mrn, accession number, dob, gender, study procedure) has been updated with another patient's metadata (patient name, mrn, accession number, dob, gender, study procedure).This may result in patient's images being labeled incorrectly with another patient's metadata and associated with the wrong patient record.2.As a result of incorrect image demographics, the mislabeled images may not be associated with the record for the patient that had an imaging study.3.An issued report on a study that is sent to the stratus imaging system via hl7, may get attached to another patient's study.This may result in a report being associated with the incorrect patient study.4.As a result of incorrect report association described above, some patients will have missing reports with no report being displayed in the study.The incorrect association of image and report metadata across imaging studies can occur within your facility or with patient records from another facility.
Additional Manufacturer Narrative
Change healthcare (chc) has identified an issue where, under certain circumstances, information from hl7 messages received by the stratus imaging pacs/ imaging share system have been incorrectly associated with another patient's study.No patient harm was reported as a result of this issue.The root cause of the issue was a design deficiency resulting from code introduced which handles linking between studies and reports for a subset of new procedures and/or reports.Change healthcare initiated a class ii recall an-05008 (res# (b)(4)) on november 1, 2023, in order to address this issue.This recall was submitted to the fda november 10, 2023.Change healthcare has applied a software patch to the impacted medical device to remediate this issue on november 1, 2023.Change healthcare is working directly with our customers to identify and address the impacted patient data.

• Brand Name: CHANGE HEALTHCARE STRATUS IMAGING PACS
• Common Device Name: CHANGE HEALTHCARE STRATUS IMAGING PACS
• Manufacturer (Section D): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie rd; richmond, british columbia V6X3G 5; CA V6X3G5
• Manufacturer (Section G): CHANGE HEALTHCARE CANADA COMPANY; 10711 cambie rd; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: alona golik ; 10711 cambie rd; richmond, british columbia V6X3G-5 ; CA V6X3G5
• MDR Report Key: 18193816
• Report Number: 8022257-2023-00001
• Device Sequence Number: 7790694
• Product Code: LLZ
• UDI-Device Identifier: 17540262160093
• UDI-Public: (01)17540262160093(10)010400
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K203249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Modification/Adjustment,Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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: 1.4
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8022257-11-01-2023-00002
• Patient Sequence Number: 1
• Patient Sex: Unknown