BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 1826724 · Received September 1, 2010

    Report

    Report Number
    9610483-2010-00003
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LAERDAL SILICONE RESUSCITATOR (LSR) DEVICE WAS RETURNED TO LAERDAL MEDICAL (B)(4) AND THEN TO THE MFR (B)(4) FOR EVAL. THE RETURNED LSR WAS FOUND TO HAVE PARTS DATED 1991, MAKING THE DEVICE 19 YRS OLD. (B)(4). THE DFU FOR THE LSR HAS A SECTION ON LONG TERM STORAGE INSTRUCTING THE USER TO PERFORM FUNCTIONAL TESTS AT A REGULAR INTERVAL (AT LEAST ANNUALLY). THE CURRENT DFU ALSO INSTRUCTS THE USER TO CLEAN ALL PARTS AND ACCESSORIES BEFORE FIRST TIME USE, AND TO PERFORM THE FUNCTION TEST AFTER REASSEMBLY. THERE IS NO TREND FOR THIS TYPE OF OCCURRENCE AND THIS INCIDENT IS CONSIDERED AN UNUSUAL EVENT.

    Description of Event or Problem · 1

    (B)(6) HAS INFORMED LAERDAL MEDICAL CORP (B)(4) OF A PT INCIDENT AT A (B)(6) HOSPITAL INVOLVING AN ADULT LAERDAL SILICONE RESUSCITATOR (LSR). IT WAS REPORTED THAT ON (B)(6) 2010, AN LSR WAS BEING USED BY A NURSE WHO EXPERIENCED AIR RESISTANCE WHEN SHE TRIED TO VENTILATE A (B)(6) MALE PT. THE LSR WAS IMMEDIATELY REPLACED WITH A SPARE RESUSCITATOR AND THERE WAS NO HARM TO THE PT. UPON INVESTIGATION, THE HOSPITAL FOUND THAT THE LIP VALVE DID NOT OPEN AS INTENDED. THE HOSPITAL REPORTS THAT THE LSR WAS BEING USED FOR THE FIRST TIME, FUNCTIONAL TESTING OF THE LSR HAD NOT BEEN PERFORMED PRIOR TO USE, AND STORAGE TIME AT THE HOSPITAL IS NOT KNOWN OR IF IT HAD BEEN CLEANED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL, A.S. ADULT RESUSCITATOR 84291

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other