MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) NUC 5I5 OS IMAGE EPICENTER 7.X; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 443972

Device Problem Computer System Security Problem (2899)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Event Description

It was reported that while using nuc 5i5 os image epicenter 7.X a cybersecurity breach was observed by the hospital personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that may 1st the hospital suffered a cyber attack.Since then they have scanned and found the epicenter computer has been affected.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00967 was sent in error.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.A vulnerability that has been exploited and is reported and after evaluation is found to be a controlled risk where no data was change, edited, or manipulated and therefore the risk of patient harm is determined to be sufficiently low.The is not impacted.

Event Description

It was reported that while using nuc 5i5 os image epicenter 7.X a cybersecurity breach was observed by the hospital personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that may 1st the hospital suffered a cyber attack.Since then they have scanned and found the epicenter computer has been affected ".

• Brand Name: NUC 5I5 OS IMAGE EPICENTER 7.X
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11967322
• MDR Text Key: 280686816
• Report Number: 1119779-2021-00967
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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
• Device Operator: Other
• Device Catalogue Number: 443972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1