Model Number 191126 |
Device Problems
Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2021 |
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine made a popping noise and began smoking at power up.The biomed stated that the machine was in rinse mode when it powered off during a thunderstorm.The machine cannot power on.The biomed also noted arcing damage to the mother board and power logic board.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.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine made a popping noise and began smoking at power up.The biomed stated that the machine was in rinse mode when it powered off during a thunderstorm.The machine cannot power on.The biomed also noted arcing damage to the mother board and power logic board.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.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
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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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine made a popping noise and began smoking at power up.The biomed stated that the machine was in rinse mode when it powered off during a thunderstorm.The machine cannot power on.The biomed also noted arcing damage to the mother board and power logic board.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.Additional information was requested, however a response has not been received.No parts were returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Correction: a6.
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Search Alerts/Recalls
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