BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS¿ CPR CHEST COMPRESSION SYSTEM

    MDR report key: 14575396 · Received June 2, 2022

    Report

    Report Number
    0003015876-2022-00833
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    December 1, 2021
    Report Date
    November 29, 2022
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K161768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. STRYKER WILL NOT REQUEST ANY INFORMATION WHICH CAN IDENTIFY, DIRECTLY OR INDIRECTLY, A PERSON TO BE IN ACCORDANCE WITH REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. THE CUSTOMER'S DEVICE WILL NOT BE RETURNED TO STRYKER FOR THE EVALUATION. SERIAL NUMBER OF THE DEVICE IS NOT AVAILABLE. CLINICAL REVIEW OF THE REPORTED EVENT WAS PERFORMED AND IT CAN NOT BE EXCLUDED THAT THE LIVER LACERATION WAS CAUSED BY LUCAS COMPRESSIONS. AS DESCRIBED, INJURIES TO THE LIVER OCCUR WITH BOTH MANUAL AND MECHANICAL CPR.

    Additional Manufacturer Narrative · 0

    SECTION D3 MANUFACTURER ENTITY OF INITIAL MDR INDICATES: PHYSIO-CONTROL, INC. - 3015876. SECTION D3 MANUFACTURER ENTITY OF INITIAL MDR SHOULD INDICATE: JOLIFE AB - 3005445717. SECTION G1 MANUFACTURING SITE FOR DEVICES OF INITIAL MDR INDICATES: PHYSIO-CONTROL, INC. - 3015876. SECTION G1 MANUFACTURING SITE FOR DEVICES OF INITIAL MDR SHOULD INDICATE: JOLIFE AB - 3005445717. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A LITERATURE SEARCH IDENTIFIED A CASE OF LIVER INJURY TO A PATIENT WITH PECTUS EXCAVATUM AFTER USE OF THE LUCAS DEVICE. IT IS UNKNOWN IF THE DEVICE DID OR DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    A LITERATURE SEARCH IDENTIFIED A CASE OF LIVER INJURY TO A PATIENT WITH PECTUS EXCAVATUM AFTER USE OF THE LUCAS DEVICE. IT IS UNKNOWN IF THE DEVICE DID OR DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196765 LUCAS¿ CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL/DRM DRM JOLIFE AB - 3005445717 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other