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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS¿ CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL / DRM
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JOLIFE AB - 3005445717 LUCAS¿ CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL / DRM Back to Search Results
Model Number LUCAS 2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 05/10/2018
Event Type  Death  
Manufacturer Narrative
(b)(4).Physio-control completed a clinical evaluation of the reported event and concluded that due to the limited information available, it was not possible to determine if the internal organ damage and rib fracture were related to the chest compressions.It could not be excluded that the mechanical chest compressions from the device may have contributed to the reported internal organ damage and rib fracture.The cause of the reported injury was not conclusively determined; however the reported injury is consistent with injuries that are known to be associated with both manual and mechanical chest compressions.In the lucas instruction for use it is written, skin abrasions, bruising and soreness of the chest are common during the use of the lucas chest compression system.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Device not evaluated by manufacturer.
 
Event Description
It was reported to physio-control that the use of a lucas 2 chest compression system led to some internal organ damage and rib fracture in a (b)(6) year old female during a cardiac arrest.The patient survived treatment during the event; however passed away at the hospital.No further details about the event were provided.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Proper operation was observed through functional and performance testing.The cause of the reported issue was not determined.The device was subsequently returned to the customer.The data stored by the device was downloaded and sent to jolife for review.Jolife reported that the internal device clock had stopped functioning and the specific data file(s) for the reported event could not be identified.
 
Event Description
It was reported to physio-control that the use of a lucas 2 chest compression system led to some internal organ damage and rib fracture in a (b)(6) year old female during a cardiac arrest.The patient survived treatment during the event; however passed away at the hospital.No further details about the event were provided.
 
Manufacturer Narrative
Medwatch report (legal manufacturer) indicates: physio-control, inc.- (b)(4).Medwatch report (legal manufacturer) should indicate: jolife (b)(4).
 
Event Description
It was reported to physio-control that the use of a lucas 2 chest compression system led to some internal organ damage and rib fracture in a (b)(6) female during a cardiac arrest.The patient survived treatment during the event; however passed away at the hospital.No further details about the event were provided.
 
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Brand Name
LUCAS¿ CPR CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL / DRM
Manufacturer (Section D)
JOLIFE AB - 3005445717
scheelevagen 17
ideon science park
lund WA SE-22 3 70
SE  SE-223 70
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
ideon science park
redmond WA 98052
Manufacturer Contact
meg marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7583919
MDR Text Key110534320
Report Number0003015876-2018-00904
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberLUCAS 2
Device Catalogue Number99576-000024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/11/2018
Date Manufacturer Received07/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age69 YR
Patient Weight58
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