A fresenius regional equipment specialist (res) was called onsite to repair a 2008k2 hemodialysis (hd) machine that reportedly had no power and could not be powered on.There was no patient connected to the machine at the time of the incident.No harm to any patients, staff, or any other individual occurred as a result of this event.The res found that power plug sparked when plugged into the hospital's electrical outlet.No damage to the power supply or the power plug was observed.No burn damage was visible on the power plug.The res reseated the power supply cable to resolve the issue.Functional testing performed by the res confirmed that the system was operating properly.No parts are available to be returned to the manufacturer for evaluation.
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The 2008k2 hemodialysis machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res found that power plug sparked when plugged into the hospital's electrical outlet.No damage to the power supply or the power plug was observed.No burn damage was visible on the power plug.The res reseated the power supply cable to resolve the issue.Functional testing performed by the res confirmed that the system was operating properly.No parts were available to be returned to the manufacturer for evaluation.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.The investigation into the cause of the reported problem was able to confirm the failure mode.The res confirmed that the power plug sparked when plugged into the hospital¿s electrical outlet.Therefore, the complaint has been deemed confirmed.
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