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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number V2 INTEGRATED MAI 700
Device Problems No Display/Image (1183); Inadequate User Interface (2958)
Patient Problem Insufficient Information (4580)
Event Date 12/03/2020
Event Type  malfunction  
Event Description
The central station's screen went black, the device was unplugged and plugged back in however the screen remained dark.This resulted in a loss of centralized patient monitoring.The central monitor was replaced and upon further inspection, an issue with the power supply was identified.The manufacturer responded to this event.Ge field engineer has been on-site to evaluate the power supply and begin investigation on root cause.Ge has provided interim loaner central station until the issue is resolved and hospital owned central stations are fixed.
 
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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 Key11027148
MDR Text Key222068636
Report Number11027148
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/09/2020
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 NumberV2 INTEGRATED MAI 700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2020
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer12/17/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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