MAUDE Adverse Event Report: GE HEALTHCARE SYSTEMS CARESCAPE CSCS CENTRAL STATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number CSCS V2 RUNNING SOFTWARE VER 7.0.7

Device Problems Computer Software Problem (1112); Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  Injury  

Event Description

Ge central station model v2 ver.7, after receiving software upgrade patch from ver.7.0.6.To ver.7.0.7.Central station fails to return patients vital signs display to the screen upon reboot.Ver.7.0.7 software was distributed to be a stop gap solution to prevent software virus infections such as wanna cry.An unintended result of installing the software patch on the central station (cscs) is: when rebooting the cscs the screen will flash all beds with a crisis alarm displaying "no comm" and fail to redisplay the patients physiological parameters or cardiac alarms.The solution for a successful reboot requires biomedical engineering support.The potential loss of patient view during a no-com display particularly in telemetry units where the central station (cscs) is the only source of view could be catastrophic with missed alarms and unwatched patients.Manufacturer response: for centralized physiological monitoring, carescape cscs central station (per site reporter).Manufacture is aware of the problem and is working to issue revised software with in the next month.

Event Description

Ge central station model v2 ver.7, after receiving software upgrade patch from ver.7.0.6.To ver.7.0.7.Central station fails to return patients vital signs display to the screen upon reboot.Ver.7.0.7 software was distributed to be a stop gap solution to prevent software virus infections such as wanna cry.An unintended result of installing the software patch on the central station (cscs) is: when rebooting the cscs the screen will flash all beds with a crisis alarm displaying "no comm" and fail to redisplay the patients physiological parameters or cardiac alarms.The solution for a successful reboot requires biomedical engineering support.The potential loss of patient view during a no-com display particularly in telemetry units where the central station (cscs) is the only source of view could be catastrophic with missed alarms and unwatched patients.Manufacturer response for centralized physiological monitoring, carescape cscs central station (per site reporter)
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manufacture is aware of the problem and is working to issue revised software with in the next month.

• Brand Name: CARESCAPE CSCS CENTRAL STATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE HEALTHCARE SYSTEMS; 8200 west tower ave.; milwaukee WI 53223
• MDR Report Key: 7391828
• MDR Text Key: 104169908
• Report Number: 7391828
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2018,03/16/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CSCS V2 RUNNING SOFTWARE VER 7.0.7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention