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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 09/02/2021
Event Type  Death  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.A clinical review was performed and it was determined that injuries to the liver happens with both manual and mechanical cpr.From this reported case it can not be excluded that the liver laceration was caused by compressions from lucas cpr.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.
 
Event Description
A customer contacted physio-control to report that liver laceration was observed when the device was used on a (b)(6) man during cardiopulmonary resuscitation.The device was immediately stopped upon restoration of cardiac output and measures were taken to reduce bleeding.The patient associated with the reported event did not survive.
 
Event Description
A customer contacted physio-control to report that liver laceration was observed when the device was used on a 78-year -old man during cardiopulmonary resuscitation.The device was immediately stopped upon restoration of cardiac output and measures were taken to reduce bleeding.The patient associated with the reported event did not survive.
 
Manufacturer Narrative
Section d3, manufacturer entity of the initial medwatch report indicates physio-control, inc.- 3015876.Section d3, manufacturer entity of the initial medwatch report should indicate jolife ab - 3005445717.Section g1, manufacturing site for devices of the initial medwatch report indicates physio-control, inc.- 3015876.Section g1, manufacturing site for devices of the initial medwatch report should indicate jolife ab - 3005445717.
 
Manufacturer Narrative
Stryker contacted the customer multiple times regarding the serial number and evaluation of the device; however the customer informed that they are unable to identify the reported device.The device was not sent for evaluation and further investigation could not be completed.The customer believes that no mechanical failure occurred with the device.The device remains with the customer.A root cause could not be determined.
 
Event Description
A customer contacted physio-control to report that liver laceration was observed when the device was used on a 78-year -old man during cardiopulmonary resuscitation.The device was immediately stopped upon restoration of cardiac output and measures were taken to reduce bleeding.The patient associated with the reported event did not survive.
 
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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 WA SE-22 3 70
SW  SE-223 70
Manufacturer (Section G)
JOLIFE AB - 3005445717
scheelevagen 17
ideon science park
lund WA SE-22 3 70
SW   SE-223 70
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key12787871
MDR Text Key280589899
Report Number0003015876-2021-02142
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K062401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberLUCAS
Device Catalogue NumberUNK_SML
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? No
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 Age78 YR
Patient SexMale
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