BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS¿ CPR CHEST COMPRESSION SYSTEM

    MDR report key: 7583919 · Received June 8, 2018

    Report

    Report Number
    0003015876-2018-00904
    Event Type
    Death
    Date Received
    June 8, 2018
    Date of Event
    May 10, 2018
    Report Date
    September 19, 2018
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    E2014029. (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.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT (LEGAL MANUFACTURER) INDICATES: PHYSIO-CONTROL, INC. - (B)(4). MEDWATCH REPORT (LEGAL MANUFACTURER) SHOULD INDICATE: JOLIFE (B)(4).

    Description of Event or Problem · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423866 LUCAS¿ CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL / DRM DRM JOLIFE AB - 3005445717 LUCAS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death