MAUDE Adverse Event Report: CARESTREAM HEALTH CARESTREAM VUE PACS

Model Number VUE PACS

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/04/2020

Event Type  Death  

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 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.

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 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
• Type of Device: VUE PACS
• Manufacturer (Section D): CARESTREAM HEALTH; carestream health inc; 150 verona st; rochester, ny
• MDR Report Key: 9803595
• MDR Text Key: 182479111
• Report Number: 1317307-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 60889971041692
• UDI-Public: 60889971041692
• Combination Product (y/n): N
• PMA/PMN Number: K170580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VUE PACS
• Device Catalogue Number: 1201284
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other