MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ADVANTAGE WORKSTATION; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problems Computer Operating System Problem (2898); Reset Problem (3019)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

This morning, the telemetry system (scottcare) froze.Staff was in the process of adding patients to the system.After the third was entered the system did not respond.System reboot occurred per staff.Biomed was called and they came to work on the system.After 3 hours of time, the system became functional.Staff called to cancel patient for the day, as we did not have an idea to how long the system would be down, while the fixes were being worked on.

• Brand Name: ADVANTAGE WORKSTATION
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): GE MEDICAL SYSTEMS; 3000 n. grandview blvd w-450; waukesha WI 53188
• MDR Report Key: 7946319
• MDR Text Key: 123069279
• Report Number: 7946319
• Device Sequence Number: 0
• Product Code: LLZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1