BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICON RESUSCITATOR (LSR)

    MDR report key: 7191939 · Received January 15, 2018

    Report

    Report Number
    9610483-2018-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Report Date
    December 18, 2017
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTM
    Removal / Correction Number
    Z-517-4 FROM 2004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THEY ONLY HAVE A FEW VERY OLD RESUSCITATORS THAT ARE USED ABOUT 2-3 TIMES PER YEAR. BASED UPON PHOTOS OF THE ACTUAL DIS-ASSEMBLED LSR INVOLVED IN THIS EVENT: THIS 2003 VINTAGE LSR INTAKE VALVE DESIGN WAS AFFECTED BY A FEB 2004 RECALL (2003-R-04, US FDA Z-517-4, MARKET CORRECTION) WHERE THE INTAKE VALVE AND ASSEMBLY (INNER PART W/ UMBRELLA VALVE) WAS REPLACED BY THE CURRENT INTAKE VALVE'S INNER PART WHICH USES A FLAT CIRCULAR "RING" MEMBRANE INTAKE VALVE. WHEN EXPANDING A STORED COLLAPSED LSR SILICON BAG WITH THIS OLD STYLE INNER PART IT WAS POSSIBLE TO CONTACT AND DISLODGE THE UMBRELLA INTAKE VALVE - THIS IS NOT POSSIBLE ON THE CURRENT LSR INNER PART AND MEMBRANE INTAKE VALVE. THIS USER WAS REQUESTED TO DISPOSE OF ALL OF THEIR OUT-OF-DATE LSR INTAKE INNER PARTS AND REPLACE THEN WITH CURRENT LSR INTAKE VALVES.

    Description of Event or Problem · 1

    AS REPORTED FROM A HOSPITAL IN (B)(6): AN ADULT LAERDAL SILICONE RESUSCITATOR ( LSR) WHICH HAD BEEN STORED COMPRESSED IN A "CASE/TOOLBOX" WAS USED (EVENT DATE UNKNOWN) ON A HOSPITALIZED PATIENT WITH BREATHING ISSUES. WHEN THEY WENT TO USE THE LSR NO VENTILATIONS COULD BE PROVIDED BECAUSE THE INLET UMBRELLA VALVE HAD BEEN DISLODGED AND WAS LOOSE INSIDE THE SILICONE BAG. THE PATIENT WAS LATER PRONOUNCED DEAD DUE TO HYPOXIA (DATE/TIME UNKNOWN). THERE ARE NO RECEIVED MEDICAL CLAIMS THAT THIS LOSS OF VENTILATION (OBVIOUS TO USER) CAUSED ANY HARM TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36269 LAERDAL SILICON RESUSCITATOR (LSR) MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A/S ADULT LSR 2903

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR