BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS(T) CPR CHEST COMPRESSION SYSTEM

    MDR report key: 3172889 · Received June 17, 2013

    Report

    Report Number
    3015876-2013-00511
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT OBSERVE ANY MALFUNCTIONS OF THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT. IT WAS OBSERVED THAT THE DEVICE WAS NOT PLACED CORRECTLY ON THE PATIENT'S CHEST. IT WAS PLACED TOO LOW AND NOT ACCORDING THE INSTRUCTIONS FOR USE. ONE OF THE AMBULANCE CREW-MEMBERS REPORTED THAT THE DEVICE HAD MOVED DURING USE AND THAT IT WAS NOT NOTICED AND CORRECTED BY THE CREW. AFTER THE DEVICE EVALUATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH THE OPTION FOR ADDITIONAL TRAINING ON THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) THE INITIAL MEDWATCH REPORT INDICATES: PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT OBSERVE ANY MALFUNCTIONS OF THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT. IT WAS OBSERVED THAT THE DEVICE WAS NOT PLACED CORRECTLY ON THE PATIENT'S CHEST. IT WAS PLACED TOO LOW AND NOT ACCORDING THE INSTRUCTIONS FOR USE. ONE OF THE AMBULANCE CREW-MEMBERS REPORTED THAT THE DEVICE HAD MOVED DURING USE AND THAT IT WAS NOT NOTICED AND CORRECTED BY THE CREW. AFTER THE DEVICE EVALUATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH THE OPTION FOR ADDITIONAL TRAINING ON THE USE OF THE DEVICE. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT OBSERVE ANY MALFUNCTIONS OF THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND AFTER UNRELATED REPAIRS WERE PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CUSTOMER REPORTED THAT THEIR INVESTIGATION OF THE ISSUE HAS CONCLUDED THAT THE LIKELY CAUSE OF THE LACERATION TO THE PATIENT WAS DUE TO A FAILURE TO USE THE DEVICE STABILIZATION STRAP (BECAUSE IT WAS MISSING) IN CONJUNCTION WITH THE DEVICE NOT BEING PAUSED AS THE PATIENT WAS BEING MOVED ONTO THE "SCOOP" WHICH LEAD TO THE DEVICE SLIPPING OFF THE PATIENT'S CHEST (STERNUM) AND CAUSING THE TEARING LACERATION. REPLACEMENT STABILIZATION STRAPS HAVE BEEN PROVIDED TO THE CUSTOMER. ADDITIONAL TRAINING REGARDING DEVICE USE HAS ALSO BEEN OFFERED. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT USE ERROR OF THE DEVICE LIKELY CAUSED THE INJURY OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL BUSINESS DEVELOPMENT MANAGER THAT A PATIENT HAD A PUNCTURE WOUND IN THE CHEST FOLLOWING THE USE OF A DEVICE FOR AUTOMATED CPR. THE PATIENT WAS A (B)(6) MAN. THE PATIENT'S TISSUE WAS EXPOSED AND THE STERNUM WAS VISIBLE. THE PATIENT WAS FOUND IN A PULSELESS ELECTRICAL ACTIVITY (PEA) CARDIAC ARREST ON THE ARRIVAL OF THE AMBULANCE CREW. THE CREW THEN APPLIED THE DEVICE FOR AUTOMATED CPR ON THE PATIENT. THE DEVICE'S SUCTION CUP WAS ATTACHED DURING THE ENTIRE EVENT, IT DID NOT COME OFF AND IT WAS INTACT AFTER THE EVENT. THE DEVICE'S STABILIZATION STRAPS WERE NOT USED, AS THEY WERE MISSING. THE WOUND WAS DISCOVERED WHEN THE PATIENT WAS MOVED TO THE AMBULANCE. THE CREW THEN STARTED MANUAL CPR. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274146 LUCAS(T) CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability