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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 Break (1069); No Display/Image (1183); Loss of Power (1475); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 07/08/2021
Event Type  malfunction  
Event Description
Central patient monitoring station lost power, the screen went black, and made a popping noise. Clinical staff verified that the device was plugged in and notified biomedical engineering. Biomedical engineering replaced the device with a function one and sequestered the broken device for later investigation.
 
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Brand NameCARESCAPE CENTRAL STATION
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 west tower avenue
milwaukee WI 53223
MDR Report Key12525408
MDR Text Key273112839
Report Number12525408
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 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV2 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 FDA09/16/2021
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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