A user facility biomedical technician reported a fresenius 2008k2 machine with a visibly burned and melted power plug.The biomed confirmed that the there was no patient involvement, and confirmed they replaced the power plug to resolve the issue and return the machine to service.The biomed reported that the power plug was discarded, and is not available for return, and photographs of the power plug are not available.Due diligence attempts were exhausted, but additional information was not provided.If additional information is provided, a supplemental report will be submitted.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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