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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC MAC-LAB HEMODYNAMIC MONITORING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC MAC-LAB HEMODYNAMIC MONITORING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Catalog Number 2099200-002
Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)
Patient Problem No Information (3190)
Event Date 06/28/2018
Event Type  malfunction  
Event Description
Patient on the table in cath lab 3 for a procedure.When entering the patient into maclab, the system displayed that the amplifier was not available.Staff did troubleshooting by unplugging and plugging the amplifier back in and rebooting the system without success.Patient had to be moved to another room.
 
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Brand Name
MAC-LAB HEMODYNAMIC MONITORING SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
9900 innovation drive
wauwatosa WI 53226
MDR Report Key7762097
MDR Text Key116448794
Report Number7762097
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 07/27/2018
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 Catalogue Number2099200-002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2018
Event Location Hospital
Date Report to Manufacturer08/08/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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