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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC-LAB COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC-LAB COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Device Problems Failure to Transmit Record (1521); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 04/29/2021
Event Type  malfunction  
Event Description
Ge medical systems (b)(6) shuts down partially without warning with patient on table. Health care providers are unable to restart auto vitals, unable to record pressures, etc.
 
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Brand NameMAC-LAB
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 west tower avenue
milwaukee WI 53223
MDR Report Key11894201
MDR Text Key252966409
Report Number11894201
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 Risk Manager
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2021
Event Location No Information
Date Report to Manufacturer05/27/2021
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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