BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAERDAL SILICON RESUSCITATOR

    MDR report key: 2349584 · Received November 18, 2011

    Report

    Report Number
    9610483-2011-00005
    Event Type
    Death
    Date Received
    November 18, 2011
    Date of Event
    October 10, 2011
    Report Date
    November 18, 2011
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAFF AT (B)(6) HOSPITAL AND FUNCTIONALLY CHECKED THE AFFECTED LSR THE MORNING OF THE INCIDENT WITH NO ISSUES FOUND. FOLLOWING THIS INCIDENT, THE MEDICAL OFFICER IN CHARGE OF THE RESUSCITATION DID A FUNCTIONAL TEST OF THE LSR AND IT PASSED. THE HOSPITAL STERILIZED THIS LSR AND RETAINED IF FOR EVALUATION. (B)(6) FROM (B)(4) VISITED THE HOSPITAL AND WITH OFFICE STAFF THE LSR WAS AGAIN TESTED AND IT PASSED ALL TESTS. THE AFFECTED LSR WAS FOUND TO BE FULLY FUNCTIONAL WITH NO NONCONFORMANCES. THE ADULT LSR PT VALVE DOES NOT HAVE THE 35 CMH20 PRESSURE RELIEF POP-OFF VALVE THAT IS USED ON THE CHILD AND PRETERM SIZED LSRS. THE MAXIMUM INSPIRATORY PRESSURE IS NOT LIMITED ON THE ADULT LSR. NO PRODUCT CORRECTIVE ACTIONS ARE RECOMMENDED.

    Description of Event or Problem · 1

    (B)(6) HAS INFORMED LAERDAL MEDICAL CORPORATION OF A PT INCIDENT FROM (B)(6) INVOLVING AN ADULT LAERDAL SILICONE RESUSCITATOR (LSR). ON (B)(6) 2011, FOLLOWING A PCT TRANSFUSION THE PT DEVELOPED ACUTE BREATHLESSNESS (RR=40/MIN), WAS DESATURATED (70%) AND HAD SEVERE PULMONARY EDEMA. A LSR AS USED TO RESUSCITATE THE PT BUT THE USER REPORTED FEELING BAG RESISTANCE, SAW NO CHEST RISE AND SATURATION CONTINUED TO DROP TO 50-60%. THE LSR WAS REPLACED WITH ANOTHER, CPR WAS STARTED AND SATURATION RETURNED TO 100%. THE PT WAS TRANSFERRED TO MICU AND PASSED AWAY 9 DAYS LATER ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICON RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A.S. ADULT RESC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death