MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number V2 INTEGRATED MAI 700

Device Problems No Display/Image (1183); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

Staff reported that the central station screen went black.This resulted in a loss of centralized patient monitoring.A biomedical engineering technician came to the unit and replaced the fuses in the central station.The central station was then turned on and started to smoke.The central station was then turned off and sequestered for further investigation.

• Brand Name: CARESCAPE CENTRAL STATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 11403970
• MDR Text Key: 234447934
• Report Number: 11403970
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

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: No Information
• Device Model Number: V2 INTEGRATED MAI 700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1