A product deficiency was identified due to an increase in complaints for failures of the r100 component of the main electronics board (parts 8-35003665-01 and 8-206623-01).The supplier, inpeco, determined that the issue is from the r100 component of the hettich centrifuge board which was too small to withstand a current spike.Hettich released an enhanced main board revision 06 with a different r100 resistor.It is considered acceptable to continue using the automation system because the issue does not impact operator nor patient safety.The accelerator aps operations manual and the centrifuge operations manual were reviewed and show that troubleshooting and safety information is provided.There have been no reported injuries for this issue.If the electrical components of the main electronics board fail, it will shut down the centrifuge module.If the centrifuge shuts down, the operator will receive an error message.The frequency of this hazard was assessed and it was determined that though there was a trend in complaints, the overall frequency of low had not changed from the predicted frequency as outlined in the risk management file.
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The customer reported a smell of smoke and then the centrifuge module would not power up.There was no visible smoke or fire reported.There was no personal injury, impact to patient management, or facility damage reported.Upon a site visit by abbott field service it was noted that there was damage to the r100 component, but no evidence of damage to any other parts.
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