BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCUS PHYSIO CONTROL

    MDR report key: 2854161 · Received November 8, 2012

    Report

    Report Number
    2854161
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 8, 2012
    Manufacturer
    PHYSIO-CONTROL INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS FOUND TO BE IN CARDIAC ARREST AND THE RESPONSE TEAM WAS CALLED TO PERFORM CARDIOPULMONARY RESUSCITATION (CPR). THE LUCAS 2, AN EXTERNAL CHEST COMPRESSION UNIT, WAS PLACED ON THE PATIENT. AFTER 15 SECONDS, COMPRESSIONS WERE PAUSED FOR REPOSITIONING AND THE LUCAS 2 LOST ALL POWER AND WOULD NOT TURN ON. THE LUCUS 2 WAS REMOVED FROM THE PATIENT AND THE BATTERY WAS REMOVED FROM THE UNIT AND REPLACED. THE LUCUS 2 WORKED FINE WHEN TESTED PRIOR TO PLACING THE UNIT BACK ON THE PATIENT. THE LUCUS 2 WAS ONCE AGAIN PLACED ON THE PATIENT AND IMMEDIATELY LOST ALL POWER AGAIN. THE LUCUS 2 WAS REMOVED FROM THE PATIENT. THE FAILURE OF THE LUCUS 2 DID NOT HAVE AN IMPACT ON THE PATIENT'S OUTCOME--MANUAL COMPRESSIONS WERE PERFORMED ON THE PATIENT. THE LUCUS 2 WAS REMOVED FROM SERVICE. THE RESPONSE TEAM STAFF TRIED TO DUPLICATE THE FAILURE, BUT THEY COULD NOT. THE UNIT WAS SENT TO BIOMEDICAL ENGINEERING FOR INSPECTION. BIOMEDICAL ENGINEERS COULD NOT DUPLICATE THE FAILURE, EITHER. INITIAL INSPECTION DID NOT REVEAL ANY UNUSUAL ITEMS OR OCCURRENCES. THE BATTERY WAS IN THE PROPER POSITION AS WAS THE PISTON. THE BIOMED TECH FOLLOWED THE SAME PROCEDURE AS THE RESPONSE TEAM STAFF WITH PLACEMENT OF THE UNIT ON A CPR DOLL AND THE LUCUS 2 DID NOT FAULT. THE DEVICE WAS RUN FOR THREE HOURS, PAUSING AND STARTING RANDOMLY, AND NO FAILURE OCCURRED. THE MANUFACTURER WAS CONTACTED AND THEIR TECHNICIAN WAS UNABLE TO REPRODUCE ANY PROBLEMS WITH THE UNIT. THE TECH RECOMMENDED RETURNING THE UNIT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE UNIT WAS RETURNED TO THE MANUFACTURER WITH REPORT PENDING AT THIS TIME.THE WALL OUTLET WAS NOT TESTED. IT IS UNKNOWN IF THE DEVICE WAS PLUGGED BACK INTO THE SAME OUTLET OR A DIFFERENT ONE. THIS FACILITY HAS HAD NO OTHER ISSUES WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUCUS PHYSIO CONTROL COMPRESSION, CARDIAC, EXTERNAL DRM PHYSIO-CONTROL INC LUCAS 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *