BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 384456 · Received March 27, 2002

    Report

    Report Number
    9610483-2002-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2002
    Report Date
    March 20, 2002
    Manufacturer
    ASMUND S. LAERDAL A/S
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MOLDING IRREGULARITY IN THE PRESSURE REGULATOR, CATALOG # 851202, HAS BEEN IDENTIFIED BY THE MFR THAT MAY PREVENT FREE MOVEMENT OF THE SPRING-LOADED REGULATOR VALVE STEM IN SOME MODELS OF LAERDAL SILICONE RESUSCITATORS. THIS COULD MEAN THAT IN SOME CASES A PRESSURE OF MORE THAN THE SPECIFIED 45 CM H2O IS NECESSARY TO OPEN THE PRESSURE REGULATOR. POTENTIAL CONSEQUENCE: DELIVERY OF HIGHER THAN INTENDED PRESSURE TO THE PT. ADDITIONALLY, ONCE OPENED, THE PRESSURE REGULATOR COULD BECOME STUCK AND REMAIN IN THE OPEN POSITION. POTENTIAL CONSEQUENCE: A SIGNIFICANT LEAK THAT DIVERTS VENTILATING GAS TO THE ATMOSPHERE RATHER THAN TO THE PT. ONLY PRESSURE REGULATORS BEARING THE MOLD CAVITY NUMBER "4" ARE AFFECTED. TO DATE, NO FAILURE, COMPLAINT OR INCIDENT HAS BEEN REPORTED AND THE MOLDING IRREGULARITY HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM ASMUND S. LAERDAL A/S INFANT & CHILD REGULATORS 11357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA