BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS 3 CHEST COMPRESSION SYSTEM

    MDR report key: 7174420 · Received January 9, 2018

    Report

    Report Number
    3015876-2018-00031
    Event Type
    Death
    Date Received
    January 9, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 9, 2018
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K161768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO CONTACTED THE CUSTOMER, BUT THEY WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION, NOR WAS THE DEVICE RETURNED FOR EVALUATION. PHYSIO PERFORMED A CLINICAL REVIEW ON THE INFORMATION THAT WAS PROVIDED WITH THE FOLLOWING RESULTS: A CARDIAC ARREST CAN BE CAUSED BY INTERNAL BLEEDING ESPECIALLY IF THE PATIENT HAS BEEN EXPOSED TO TRAUMA. BOTH MANUAL AND MECHANICAL CPR CAN CAUSE INTERNAL BLEEDING (SEE FOOTNOTES 1, 2, 3 AND 4). THE CUSTOMER WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT, HENCE IT IS NOT POSSIBLE TO DRAW ANY CONCLUSIONS BASED ON FACTS. IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLICATIONS WERE RELATED TO THE CARDIAC ARREST, CAUSED BY TRAUMA OR THE PROVIDED CPR. WITH THE INFORMATION PROVIDED IT CANNOT BE EXCLUDED THAT LUCAS COMPRESSIONS MAY HAVE CONTRIBUTED TO THE REPORTED INTERNAL BLEEDING. FOOTNOTE 1: LUCAS 3, CHEST COMPRESSIONS SYSTEM - INSTRUCTIONS FOR USE, 100925-01 REV B, VALID FROM CO J3022, 2016 JOLIFE AB. FOOTNOTE 2: 2005 INTERNATIONAL CONSENSUS ON CARDIOPULMONARY RESUSCITATION AND EMERGENCY CARDIOVASCULAR CARE SCIENCE WITH TREATMENT RECOMMENDATIONS. PART 2: ADULT BASIC LIFE SUPPORT. RESUSCITATION, 2005. 67(2-3): P. 187-201. FOOTNOTE 3: PARADIS, N., ET AL., CARDIAC ARREST, CHAPTER: MANUAL CARDIOPULMONARY TECHNIQUES. SECOND EDITION ED. 2007, CAMBRIDGE: CAMBRIDGE UNIVERSITY PRESS. 576-577. FOOTNOTE 4: SMEKAL ET AL, CPR-RELATED INJURIES AFTER MANUAL OR MECHANICAL CHEST COMPRESSIONS WITH THE LUCAS TM DEVICE: A MULTI-CENTER STUDY OF VICTIMS AFTER UNSUCCESSFUL RESUSCITATION, RESUSCITATION 85 (2014) 1708-1712. (B)(4). REFERENCE EXEMPTION NUMBER E2014029..

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S LUCAS® 3 CHEST COMPRESSION SYSTEM WAS USED DURING RESUSCITATION EFFORTS ON A PATIENT WITH ANTERIOR STEMI AND REPORTEDLY CAUSED INTERNAL BLEEDING FROM THE LUNGS WHICH COULD NOT BE CONTROLLED, LEADING TO THE PATIENT'S DEATH. NO PATIENT DETAILS OR FURTHER INFORMATION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19033 LUCAS 3 CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB LUCAS PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R