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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
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JOLIFE AB - 3005445717 LUCAS¿ CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number LUCAS
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Death (1802)
Event Date 08/05/2019
Event Type  Death  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute.The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions.By following the instructions for use the interruption in cpr is likely to be short and not, as in this case, as long as one minute.Stryker evaluated the customer's device and was unable to duplicate the reported issue.After performing an unrelated repair, proper device operation was observed.The device was subsequently returned to the customer for use.It was noted that the batteries used with the device were manufactured in 2015.Stryker recommends that batteries be replaced approximately every three years.The likely cause of the reported issue was determined to be due to user error, as the customer had not replaced the battery after the recommended 3 year life.Initial mdr mfr 0003015876-2019-01465 was originally submitted on 09/03/2019 based on awareness date (b)(6) 2019.The device evaluation was completed on (b)(6) 2020 prompting a correction and this additional report.
 
Event Description
The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.
 
Manufacturer Narrative
F6 user facility awareness date of the initial submission was left blank.F6 user facility awareness date should be 02/25/2020.
 
Event Description
The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.
 
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Brand Name
LUCAS¿ CPR CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
JOLIFE AB - 3005445717
scheelevagen 17
ideon science park
lund SE-22 3 70
SE  SE-223 70
MDR Report Key9881681
MDR Text Key184980028
Report Number3005445717-2020-00003
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type foreign
Type of Report Initial,Followup
Report Date 08/05/2019,03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLUCAS
Device Catalogue Number99576-000033
Device Lot Number3015C620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/25/2020
Device Age5 YR
Event Location Other
Date Report to Manufacturer08/05/2019
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
Patient Weight80
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