[5309969]
Cardinal was notified through (b)(4) that a complaint had been filed regarding an adverse event involving a 6856 scale that had repeat failures of the wheel bracket assembly. According to the medwatch report the wheel bracket assembly had to be replaced every six weeks. The following is response to fda mdr report. The device was evaluated on complainant's site by (b)(4) representative ((b)(4)) with the complainant present. This evaluation determined that the root cause of the repeated failures of the wheel bracket assemblies is due to the movement of the scale around the facility in which there is repeated bouncing of the scale across thresholds in the flooring. This scale is also moved from floor to floor across a 2" threshold on an elevator. In reviewing with our engineering department this repeated movement in this environment will cause damage to the wheels and also drive the axle into the bracket of the assembly causing the bracket to cut into the axle and fail prematurely. The original intent of the design was for the scale to be movable on a smooth flat surface and not in a rough or non-uniform surface. While the wheel bracket assembly is a considered a wear item it is possible for this assembly to fail prematurely, when shock loading like that observed. The number of failures at this facility seems abnormally high but not as frequent as the complainant has reported. According to the complainant the wheel bracket assembly was replaced every six weeks. According to our records this facility has purchased six wheel kit assemblies since the scale was put into service during the latter part of 2011. This would equate to a failure approximately every 6 months and not every 6 weeks. This cannot be fully substantiated as according to our records this facility does have at least one other scale that also uses this wheel bracket assembly and it is not known whether these additional assemblies were for the scale reported in this report or not. It is our conclusion that while the failures are higher than normal, the amount of use of this device receives in an environment unfriendly to the original intent of the design is the cause of the premature failures. This design was released in 1998 in which our engineering department designed the bracket assembly to support the weight of this scale. This is only the second documented complaint regarding repeated failures of the wheel bracket assembly and in both cases it was due to the environment in which the scale was operated that caused premature failure of this assembly. Included documents used to conduct evaluation: (b)(4).
Patient Sequence No: 1, Text Type: D, B5