BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 1051327 · Received May 22, 2008

    Report

    Report Number
    9610483-2008-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 14, 2008
    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 LAERDAL SILICONE RESUSCITATOR (LSR) RETURNED TO LAERDAL MEDICAL AS (LMAS) WAS THE LATEST VERSION WITH OXYGEN RESERVOIR ATTACHED. AS RETURNED, IT DID NOT EXHIBIT DYSFUNCTION, BUT THE OXYGEN RESERVOIR OUTLET UMBRELLA-VALVE EXHIBITED PEN MARKS EXPLAINED TO BE THE RESULT OF THE CUSTOMER DEMONSTRATING THE PROBLEM WITH THE DEVICE. ANOTHER LSR WAS RETURNED FROM THE SAME CUSTOMER FOR THE SAME COMPLAINT THAT WAS VERIFIED; THAT DEVICE WAS FOUND TO HAVE THE RESERVOIR OUTLET UMBRELLA-VALVE STUCK TO ITS VALVE-SEAT. IT MAY BE THAT THIS DEVICE HAD THE SAME STICKY CONDITION AT THE TIME OF THE INCIDENT AND WAS LOOSENED BY THE CUSTOMER AT SOME STAGE BEFORE BEING SUBMITTED TO LAERDAL. THE OUTLET UMBRELLA-VALVE IS DESIGNED AND INTENDED AS A PRESSURE RELIEF MECHANISM, PREVENTING A BUILD-UP OF PRESSURE FROM THE OXYGEN SUPPLY. IF IT IS STICKING TO THE VALVE SEAT, THIS FUNCTION IS PREVENTED AND PRESSURE WILL INCREASE IN THE BAG AND THE PATIENT'S AIRWAY, ALSO PREVENTING THE PATIENT FROM EXHALING. THE DEVICE WAS EQUIPPED WITH A 45 CMH2O LIMITING POP-OFF WITH OVER-RIDE CLIP. HYPERINFLATION CAUSE BY THIS CONDITION IS THEREFORE PLAUSIBLE. THIS MALFUNCTION IS MOST LIKELY CAUSED BY REPROCESSING THE UNIT ASSEMBLED, OR ASSEMBLING THE UNIT WHEN STILL WET AFTER REPROCESSING, AND THEN FAILURE TO PERFORM A FUNCTION TEST FOLLOW REASSEMBLY. THE DIRECTIONS FOR USE FOR THE LSR STATES: "DISASSEMBLE THE LSR INTO INDIVIDUAL PARTS AS SHOWN IN THE PARTS ILLUSTRATION IN THE DIRECTIONS FOR USE", "INSPECT ALL COMPONENTS TO CONFIRM THEY ARE CLEAN AND DRY", AND "VISUALLY INSPECT AND TEST VALVE FUNCTIONS TO ENSURE PROPER OPERATIONS OF THE LAERDAL SILICONE RESUSCITATOR PRIOR TO PATIENT USE".

    Description of Event or Problem · 1

    LAERDAL MEDICAL AS RECEIVED INFORMATION ON 04/14/08 THAT A LAERDAL DISTRIBUTOR RECEIVED INFORMATION ALLEGING THAT A LAERDAL SILICONE RESUSCITATOR (LSR) DID NOT FUNCTION AS EXPECTED DURING USE ON A 2 1/2 MONTH FEMALE BABY. PER THE DOCTOR INVOLVED, THEY NOTICED SPONTANEOUS INFLATION OF THE BABY'S CHEST WITHOUT SQUEEZING THE BAG RESUSCITATOR. FOR AN UNUSUAL REASON, ALL THE FLOW OF OXYGEN FROM THE FLOW METER WAS TRANSFERRED THROUGH TE BAG RESUSCITATOR TO THE EXIT PORT CONTINUOUSLY INFLATING THE BABY'S CHEST AND LUNGS. VENTILATION WAS CONTINUED WITH ON/OFF OF THE BAG UNTIL A NEW BAG RESUSCITATOR WAS BROUGHT TO THE CHILD, WHO WAS LATER EXTUBATED WITHOUT FURTHER DETERIORATION AND COULD BE LATER DISCHARGED FROM THE INTENSIVE CARE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO