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

Model Number V2 INTEGRATED MAI 700

Device Problems Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2021

Event Type  malfunction  

Event Description

The central station had a strange smell which led the clinical staff to unplug and re-plug the central station.Once the central station rebooted, there was a popping sound, smoke, and the screen went black.Clinical staff contacted life safety and biomed who removed the device from service.This resulted in a loss of centralized patient monitoring.The central station was replaced and upon further inspection, an issue with the internal power supply assembly component was identified.

• 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: 12727425
• MDR Text Key: 279297077
• Report Number: 12727425
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1