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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB LUCAS CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFE AB LUCAS CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number 99576
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2020
Event Type  malfunction  
Event Description
We have had multiple issues with the power cord for our lucas device.This seems to be a consistent issue in several areas of the organization that utilize the lucas.The issue with the power cord involves the connector breaking, which does not allow the device to charge.The recommendation to the emergency department when we contacted stryker, was to purchase the battery back-up (which we have).Each power cord costs (b)(6).There is no way to purchase just the portion of the cord that is broken, you must purchase the entire cord.The ed has even gone as far as building a special "shelf" for the device to avoid kinking the cord which has caused failures.Manufacturer response for lucas 3 chest compression device, lucus (per site reporter).Yes: recommended purchasing additional equipment (back up battery, additional chord/connector).
 
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Brand Name
LUCAS CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
JOLIFE AB
11811 willows rd ne
redmond WA 98052
MDR Report Key10919014
MDR Text Key218686030
Report Number10919014
Device Sequence Number1
Product Code DRM
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 10/23/2020
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 Number99576
Device Catalogue Number99576-000043
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/23/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/30/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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