Catalog Number 191130 |
Device Problems
Thermal Decomposition of Device (1071); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2024 |
Event Type
malfunction
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Event Description
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A user facility reported a fresenius 2008t hemodialysis (hd) machine had thermal decomposition of the power supply.A field service technician (fst) replaced the power supply.Upon follow-up, the biomedical technician (bmt) stated a burning smell was noted and the machine began smoking when the machine was turned on and was immediately turned off.Per bmt the power control board within the power supply appeared burnt.The bmt confirmed the smoke detectors were not triggered.The bmt reported there was no spark or flame observed.The power supply was noticed during annual inspection preventative maintenance.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.Per bmt the power supply was replaced by the fst and the issue was resolved.The bmt reported the unit was returned to service at the user facility without reoccurrence of the event.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine has approximately 831 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the power supply component was available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: 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 reported a fresenius 2008t hemodialysis (hd) machine had thermal decomposition of the power supply.A field service technician (fst) replaced the power supply.Upon follow-up, the biomedical technician (bmt) stated a burning smell was noted and the machine began smoking when the machine was turned on and was immediately turned off.Per bmt the power control board within the power supply appeared burnt.The bmt confirmed the smoke detectors were not triggered.The bmt reported there was no spark or flame observed.The power supply was noticed during annual inspection preventative maintenance.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.Per bmt the power supply was replaced by the fst and the issue was resolved.The bmt reported the unit was returned to service at the user facility without reoccurrence of the event.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine has approximately 831 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt reported that the power supply component was available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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H3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned power supply found thermal damage to varistor (rv1) and soot on the back of the power control board (p/n 190937).There is no other damage found on the power control board, and power supply.Install the power supply (as-received condition) onto a test machine for testing.No problems during the initial power up.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.Varistor (rv1) was replaced on the power control board for retesting.No problems during power up.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.The varistor or metal oxide varistor (mov) is a special resistor that is used to protect circuits against high transient (short term) voltage.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be due to a shorted varistor rv1.
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Search Alerts/Recalls
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