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

Model Number V2 INTEGRATED MAI 700

Device Problem Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  malfunction  

Event Description

Central patient monitoring station popped and failed to reboot during preventative maintenance performed by biomedical engineering in the central monitoring unit.Biomedical engineering replaced and sequestered the device 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: 12525414
• MDR Text Key: 273112743
• Report Number: 12525414
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1