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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 V2; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION V2; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number V2 INTEGRATED MAI 700
Device Problems No Display/Image (1183); Device Emits Odor (1425); Inadequate User Interface (2958); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
The patient monitoring central station screen became "snowy", then turned black.The nursing staff on the unit unplugged and plugged the power cable back in, it started working momentarily, then the screen went black and made a very loud popping noise with a burning plastic smell.This resulted in a loss of centralized patient monitoring.Nursing/administrative staff relocated to the centralized telemetry "war room" to resume viewing all patients while the central station was replaced.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 V2
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 west tower avenue
milwaukee WI 53223
MDR Report Key11027176
MDR Text Key222068937
Report Number11027176
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 Age4 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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