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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 Smoking (1585); Material Deformation (2976); Noise, Audible (3273); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 03/18/2021
Event Type  malfunction  
Event Description
The central station was reported to have gone dark and biomed was called.A biomedical engineering technician turned the central off and back on again.Upon turning the device back on there was a popping noise and the device smoked.The device was unplugged and removed.It was discovered that the power supply assembly smelled of smoke, had scorch marks, and a deformed component.The fuses were also swapped although neither fuse failed during the power supply assembly failure.
 
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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 Key11663570
MDR Text Key245340176
Report Number11663570
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 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2021
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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