BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAERDAL SILICON RESUSCITATOR (LSR)

    MDR report key: 3918863 · Received June 25, 2014

    Report

    Report Number
    9610483-2014-00002
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    LAERDAL MEDICAL A.S. OF STAVANGER
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LSR WAS RETURNED TO LMAS AND IT PASSED ALL INSPECTIONS AND FUNCTIONAL TESTS AND MEETS ALL SPECIFICATIONS. AN OVER PRESSURE CONDITION COULD BE CREATED IF OXYGEN WAS CONNECTED TO THE LSR AND IT HAD THE OLD STYLE OF LSR INTAKE VALVE (PRE 2003); NO EXTERNAL LSR RESERVOIR VALVE WAS CONNECTED; AND THE 23 MM OD LSR INTAKE PORT THEN BLOCKED/OCCLUDED. THIS OVER PRESSURE CONDITION COULD BE RELIEVED BY DELIVERING ONE, OR MORE, LSR VENTILATIONS OR OPENING/VENTING THE BAG/AIRWAY CONDUIT. THE LSR DFU RECOMMENDS USING THE LSR RESERVOIR VALVE AND OXYGEN RESERVOIR TO DELIVER HIGHER OXYGEN CONCENTRATIONS. THE LSR OXYGEN RESERVOIR WILL NOT CONNECT TO THE LSR WITHOUT THE RESERVOIR VALVE. WITH THE LSR RESERVOIR VALVE CONNECTED THIS CONDITION COULD NOT HAVE OCCURRED. THE CURRENT LSR CONFIGURATION (SINCE 2003) IS NOT SUSCEPTIBLE TO THIS UNUSUAL USER ERROR. UNUSUAL OCCURRENCE. WE HAVE LITTLE DETAIL OF USER'S EQUIPMENT CONFIGURATIONS DURING THIS EVENT.

    Description of Event or Problem · 1

    LAERDAL MEDICAL A.S. (LMAS) IN (B)(6) HAS INFORMED LAERDAL MEDICAL CORPORATION (LMC) IN (B)(6) OF AN EVENT WHICH OCCURRED IN (B)(6). A FEMALE HOSPITAL PATIENT IN PREPARATION FOR A THYROIDECTOMY OPERATION BEGAN COUGHING. SHE WAS BEING MANUALLY VENTILATED WITH OXYGEN THROUGH A LAERDAL SILICONE RESUSCITATOR (LSR) WHILE THE ANESTHESIA MACHINE WAS PREPARED. HER OXYGEN SATURATION DECREASED OVER A 2 MINUTE TIME PERIOD AND SHE WENT INTO ASYSTOLE. THE LSR WAS REMOVED FROM THE PATIENT AND A LARGE AIR FLOW / EXHALE OCCURRED. CPR WAS PROVIDED FOR ABOUT ONE MINUTE AND CIRCULATION RETURNED. A THORAX AND ABDOMEN CT SCAN CONFIRMED PNEUMOTHORAX IN BOTH LUNGS. THE PATIENT SURVIVED THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369848 LAERDAL SILICON RESUSCITATOR (LSR) MANUAL REUSABLE RESUSCITATOR BTM LAERDAL MEDICAL A.S. OF STAVANGER ADULT 080403

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention