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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL LUCAS; COMPRESSOR, CARDIAC, EXTERNAL
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PHYSIO-CONTROL LUCAS; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208); Injury (2348)
Event Date 10/12/2018
Event Type  Death  
Event Description
Patient found down at home with an unknown down time.Brought to the ed by ems coding.Patient was called as a stemi by the ed and brought to the cath lab.She arrived intubated and on a ventilator.Patient was prepped and draped in the usual fashion.A heart catheterization was performed on the patient.The coronary arteries did not show any blockages.When crossing the aortic valve the patient lost her pulse and blood pressure.Cpr and acls were started.A code blue was called.Ccu nurses, respiratory, and ccm md's arrived to assist.Md called time of death.Injuries found on autopsy due to use of lucas chest compression device.The left subclavian artery had ruptured plaque.There were multiple tears in the pericardial sac with periaortic soft tissue hemorrhage and hemorrhage into both pulmonary hila.
 
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Brand Name
LUCAS
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
PHYSIO-CONTROL
11811 willows road, ne
redmond WA 98052
MDR Report Key8015280
MDR Text Key125334076
Report Number8015280
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 Other Health Care Professional
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2018
Event Location Hospital
Date Report to Manufacturer10/29/2018
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age25550 DA
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