BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 962696 · Received December 12, 2007

    Report

    Report Number
    9610483-2007-00005
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Report Date
    November 20, 2007
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU) FOR THE LAERDAL SILICONE RESUSCITATOR (LSR) DESCRIBE A DECONTAMINATION PROCEDURE TO BE DONE AFTER EACH USE THAT INCLUDES VISUAL INSPECTION AND REPLACEMENT OF PARTS WORN OR DAMAGED, AND REASSEMBLY OF THE DEVICE FOLLOWED BY FUNCTION TESTING TO ENSURE PROPER OPERATION OF THE RESUSCITATOR AFTER EACH REASSEMBLY. FUNCTION TESTING OF THE INCIDENT LSR FOLLOWING CLEANING AND REASSEMBLY WOULD HAVE REVEALED THE MIS-ASSEMBLY OF THE PT VALVE. USE OF THE LSR WITHOUT A LIP VALVE WOULD CAUSE VENTILATING GAS TO ESCAPE THROUGH THE EXPIRATION OPENINGS ON THE PT VALVE MAKING THE LSR NOTICEABLY NON-FUNCTIONAL TO THE USER.

    Description of Event or Problem · 1

    DURING A INCIDENT IN ENGLAND ON AN UNK DATE, A CHILD WHO HAD SUFFERED A RESPIRATORY ARREST FROM A CRASH WAS BEING VENTILATED WITH A LAERDAL SILICONE RESUSCITATOR (LSR) AND THE ANESTHETIST FOUND PRACTICALLY NO CHEST EXPANSION. A SECOND RESUSCITATOR WAS IMMEDIATELY AVAILABLE AND THE CHILD SUFFERED NO ILL-CONSEQUENCES. LATER, THE NON-FUNCTIONAL LSR WAS FOUND TO BE INCORRECTLY ASSEMBLED WITHOUT A "LIP" VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A.S. CHILD RESU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other