Model Number 190766 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Event Description
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A user facility biomedical technician (bmt) reported that a fresenius 2008t machine powered down with an audible alarm.During troubleshooting, the bmt discovered the power rocker switch and the black wire between the power rocker switch and the power control board was burnt.Additional information was requested, however to date has not been provided.
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Manufacturer Narrative
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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 field service technician (fst).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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Event Description
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A user facility biomedical technician (bmt) reported that a fresenius 2008t machine powered down with an audible alarm.During troubleshooting, the bmt discovered the power rocker switch and the black wire between the power rocker switch and the power control board was burnt.Additional information was requested, however to date has not been provided.
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Search Alerts/Recalls
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