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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFF AB LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFF AB LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number LUCAS 2
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Respiratory Distress (2045); Loss Of Pulse (2562)
Event Date 10/14/2015
Event Type  Injury  
Event Description
This patient arrived in the adult emergency department in severe respiratory distress.While undergoing investigation for condition, the patient was intubated and was receiving critical care.He had a period of absent pulses, and underwent cardiopulmonary resuscitation.There was a lucas (mechanical) device used to deliver compressions.Massive pe was later found on ct scan.Later, surgical service noted significant hemoperitoneum during bedside exploratory-lap.Surgical service concerned that mechanical compression device may have contributed to liver bleed.
 
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Brand Name
LUCAS 2 CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
JOLIFF AB
c/o laura lank, physio-control inc.
11811 willows rd ne
redmond WA 98052
MDR Report Key5480660
MDR Text Key39688374
Report Number5480660
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberLUCAS 2
Device Catalogue Number100582-01
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2015
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
Patient Weight89
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