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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB LUCAS; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFE AB LUCAS; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number 99576
Device Problems Computer Software Problem (1112); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
Patient arrived into resuscitation room in cardiac arrest via ambulance.Chest compressions were being delivered by mechanical cpr device (lucas system).Upon switching from the pre-hospital lucas system to the ed lucas system, the ed lucas system failed to properly deliver aha guidelines cpr.The ed staff immediately initiated manual chest compressions.Manufacturer response for lucas cpr compression device, lucas 3 (per site reporter).Biomedical engineering examined device.Stryker medical believes the failure is related to software or piston issue.Stryker medical to examine device friday, [date redacted].A loaner will be provided.Stryker engineer came on-site to replace the compression module control board.The engineer even completed a pm according to the field service report.The unit has been placed back into service.
 
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Brand Name
LUCAS
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
JOLIFE AB
11811 willows road ne
redmond WA 98052
MDR Report Key10726194
MDR Text Key212724870
Report Number10726194
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 Nurse
Type of Report Initial
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number99576
Device Catalogue Number99576-000063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2020
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age31755 DA
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