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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Catalog Number 99576-000067
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2023
Event Type  Injury  
Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker 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.
 
Event Description
A customer contacted stryker to report that imaging of the patient reveled vessel injury of the chest after the device was used to provide cardiopulmonary resuscitation.The customer confirmed that there was no abnormality of the device during patient use.
 
Event Description
A customer contacted stryker to report that imaging of the patient reveled vessel injury of the chest after the device was used to provide cardiopulmonary resuscitation.The customer confirmed that there was no abnormality of the device during patient use.
 
Manufacturer Narrative
Stryker performed a clinical review and it was determined that there was insufficient data within the file to determine the impact of the device use.It cannot be excluded that the vessel injury was caused by compressions from the lucas device.A stryker service representative evaluated the customer's device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
 
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Brand Name
LUCAS 3 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
SW  SE-223 70
Manufacturer (Section G)
JOLIFE AB - 3005445717
scheelevagen 17
ideon science park
lund SE-22 3 70
SW   SE-223 70
Manufacturer Contact
dara friedman
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key17218408
MDR Text Key318025958
Report Number3005445717-2023-00045
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K173553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number99576-000067
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/18/2023
Was Device Evaluated by Manufacturer? Yes
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) Other;
Patient Age56 YR
Patient SexMale
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