BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 3240869 · Received July 17, 2013

    Report

    Report Number
    9610483-2013-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LSRS ARE FROM THE FOLLOWING SIZES AND LOTS: PRETERM (85001633/82005033): LOTS 0996, 1091, 0306; PEDIATRIC (86005033): LOTS 1305, 1909. THESE LSRS ARE BETWEEN 4 AND 12 YEARS OLD. THE LSR DIRECTIONS FOR USE DO NOT SPECIFY "BOILING IN WATER" AS AN ACCEPTABLE HIGH-LEVEL DISINFECTION METHOD. THE HOSP STAFF ALTER CLEANED THE AFFECTED LSRS BY BOILING IN SOFT RAIN WATER WITH A LITTLE VINEGAR ADDED AND NOW THE HARD WATER LIME DEPOSITS ARE GONE. FOLLOWING THIS CLEANING, HOSPITAL STAFF VISUALLY INSPECTED AND FUNCTIONALLY TESTED ALL THESE LSRS WITH NO PROBLEMS FOUND. THESE LSRS WERE RETURNED TO SERVICE IN THE MATERNITY WARD.

    Description of Event or Problem · 1

    LAERDAL MEDICAL (B)(4) HAS INFORMED LAERDAL MEDICAL CORP (LMC) IN (B)(4) OF FIVE LAERDAL SILICONE RESUSCITATORS (LSR) THAT HAVE HARD WATER DEPOSITS ON AND INSIDE THE RESUSCITATORS FOLLOWING REPEATED CLEANING AND BOILING IN HARD LOCAL WATER. THIS REPORT COMES FROM A HOSPITAL LOCATED IN (B)(6). FOLLOWING A PRE-USE INSPECTION, THESE 5 AFFECTED LSRS WERE AMONG NINE RESUSCITATORS REMOVED FROM SERVICE BY THE HOSP. THE HOSP DID NOT REPORT ANY PT EVENTS WERE CAUSED BY THESE LSRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331742 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A/S PRE TERM & PEDI

    Patients

    Seq Age Sex Outcome Treatment
    1