MAUDE Adverse Event Report: CARESTREAM HEALTH CARESTREAM VUE PACS

Model Number	VUE PACS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/04/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Carestream received a complaint on (b)(6) 2020 and has started the investigation process.When additional information and facts become available, a follow-up report will be submitted within 30 days.
Event or Problem Description
The hospital site reported that the carestream vue pacs allegedly contributed to a patient death due to the system being down and patient images not accessible.
Additional Manufacturer Narrative
Follow up report for a complaint received on (b)(6) 2020.The investigation confirmed there were configuration errors with the vue pacs which can cause the system to not function intermittently.Key facts and specific patient details surrounding the event could not be obtained from the site after several attempts by the service team.The investigative findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional information become available from the site a follow report will be submitted.
Event or Problem Description
The hospital site alleges that the carestream vue pacs contributed to a patient death due to the system being down and patient images not accessible.

• Brand Name: CARESTREAM VUE PACS
• Common Device Name: VUE PACS
• Manufacturer (Section D): CARESTREAM HEALTH; carestream health inc; 150 verona st; rochester, ny
• MDR Report Key: 9803595
• Report Number: 1317307-2020-00001
• Device Sequence Number: 643598
• Product Code: LLZ
• UDI-Device Identifier: 60889971041692
• UDI-Public: 60889971041692
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: VUE PACS
• Device Catalogue Number: 1201284
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/07/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other