BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOLIFE

    MDR report key: 1564878 · Received December 21, 2009

    Report

    Report Number
    MW5014080
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 14, 2009
    Report Date
    December 21, 2009
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN GIVEN THE OPPORTUNITY TO TRIAL THE NEWEST VERSION OF THE LUCAS 2 CHEST COMPRESSION DEVICE. WE HAVE HAD SEVERAL CONCERNS THAT HAVE ARISEN REGARDING THE DEVICE UPON TRAINING STAFF ON THE DEVICE AND TRIALING THE DEVICE ON SEVERAL PTS. THE FIRST CONCERN THAT WAS SHARED WITH THE GROUP WAS DURING TRAINING WITH THE STAFF, THE BELLOWS ON THE DEVICE HAD BECOME TORN. THE BIOMEDICAL GROUP AT OUR ORGANIZATION CHECKED THE DEVICE AND FELT THAT THIS WOULD NOT HINDER THE OPERATION OF THE DEVICE DURING THE TRIAL. WE CONTACTED OUR CO'S REPRESENTATIVE TO GET US A REPLACEMENT FOR THIS PIECE. THE FACILITY HAS TWO OF THE LUCAS 1 DEVICES IN THE EMERGENCY DEPARTMENT AND THE LAB. WE EVALUATED THE BELLOWS ON THOSE DEVICES, AND IT APPEARS THAT THE BELLOW MATERIAL ON THE LUCAS 1 IS THICKER. THE SECOND CONCERN THAT HAS OCCURRED HAPPENED WHEN THE DEVICE WAS TRIALED ON A SMALLER PT THAT COINCIDENTLY HAD A FEMORAL SHEATH WITH A BALLOON PUMP POSITIONED AND AN ARTERIAL LINE. WHEN THE DEVICE WAS PLACED ON THE PT, THE PT'S BLOOD PRESSURE WAS MARKEDLY DECREASED COMPARED TO MANUAL CHEST COMPRESSIONS THAT WERE INITIATED PRIOR TO THE DEVICE'S ARRIVAL. THE BLOOD PRESSURES WITH MANUAL COMPRESSIONS RANGED FROM 110-120 SYSTOLIC. WHEN THE DEVICE WAS APPLIED, THE SYSTOLIC PRESSURES RANGED FROM 60-80 SYSTOLIC. THE DECISION TO REMOVE THE DEVICE WAS AGREED UPON AND MANUAL COMPRESSIONS WERE RESUMED. IMMEDIATELY FOLLOWING THE SYSTOLIC PRESSURES RETURNED TO 110-120 SYSTOLIC. UPON REMOVAL OF THE DEVICE, THE BELLOWS ON THE PRESSURE PAD BECAME LODGED AS THE PAD RETURNED TO ITS RESTING POSITION. THIS CAUSED THE MACHINE TO ALARM AND NOT RESET. AT THAT TIME, THE BELLOWS ALSO TORE DURING THIS EPISODE. THE MACHINE WAS TURNED ON AND OFF AND CONTINUED TO ALARM AND WOULD NOT RETURN TO ITS READY POSITION. STAFF REALIZED THE ISSUE AND WERE ABLE TO FREE THE RUBBER BELLOWS FROM THE PAD SHAFT AND THE MACHINE SUBSEQUENTLY SELF TESTED APPROPRIATELY. OUR CONCERN WITH THE SECOND INCIDENT RESTS IN THE FACT THAT THE MATERIAL ON THE DEVICE APPEARS TO BE THE FAULT. DIAGNOSIS OR REASON FOR USE: ARTIFICIAL CHEST COMPRESSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOLIFE LUCAS 2 DRM PHYSIO-CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1