BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS 3 CHEST COMPRESSION SYSTEM

    MDR report key: 11814258 · Received May 12, 2021

    Report

    Report Number
    0003015876-2021-01044
    Event Type
    Death
    Date Received
    May 12, 2021
    Date of Event
    April 1, 2021
    Report Date
    December 3, 2021
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K062401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER EVALUATED THE CUSTOMER'S DEVICE AND OBSERVED NO DEVICE MALFUNCTION. THE REPORTED ISSUE COULD NOT BE VERIFIED. AFTER PERFORMING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER BROKEN RIBS AND STERNAL FRACTURE IS A SIDE AFFECT OF CPR AND THE USE OF THE LUCAS DEVICE. PER THE OI, THE STABILIZATION STRAPS SHOULD BE USED IN EACH EVENT. IT IS UNKNOWN IF THE STRAPS WERE USED DURING THIS PATIENT EVENT. IF THEY WEREN'T, THAT COULD HAVE CONTRIBUTED TO THE REPORTED PATIENT OUTCOME.

    Additional Manufacturer Narrative · 0

    A PHYSIO-CONTROL SALES REP CONFIRMED THAT THE SERIAL NUMBER ASSOCIATED WITH THE REPORTED EVENT IS SN (B)(6) . SECTION D1 AND D4 HAVE BEEN UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT SOME INJURIES ASSOCIATED WITH RESUSCITATION WERE NOTED AT POST-MORTEM OF THE PATIENT. IT WAS OBSERVED THAT THE PATIENT'S CHEST CAGE HAD COLLAPSED AND HAD BROKEN RIBS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT SOME INJURIES ASSOCIATED WITH RESUSCITATION WERE NOTED AT POST-MORTEM OF THE PATIENT. IT WAS OBSERVED THAT THE PATIENT'S CHEST CAGE HAD COLLAPSED AND HAD BROKEN RIBS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL 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. PHYSIO-CONTROL WILL NOT REQUEST ANY PATIENT IDENTIFYING INFORMATION TO BE IN ACCORDANCE WITH REGULATION (EU) (B)(4) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT SOME INJURIES ASSOCIATED WITH RESUSCITATION WERE NOTED AT POST-MORTEM OF THE PATIENT. IT WAS OBSERVED THAT THE PATIENT'S CHEST CAGE HAD COLLAPSED AND HAD BROKEN RIBS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710245 LUCAS 3 CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB - 3005445717 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death