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Model Number 50000000E |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the arctic sun device was booting up to a red screen stating, that the device failed to start.Mss discussed that this was indicative of a loss of communication with the control panel.Biomed stated that they already replaced the isolation card and stated would rather try replacing other components from an arctic sun device and then would attempt to troubleshoot.Mss discussed the pathways and possible components with them.Biomed called back and stated that they would like to send the device in for repair.As per email response received on 06dec2021, biomed stated that there was no patient involvement, and the arctic sun device would be sent to the depot for repairs.As per sample evaluation result received on (b)(6) 2022, it was reported that the device booted up to a red screen.This was a combination of failed processor, power supply, and input output circuit cards in the card cage.Mss stated that the flow was reading zero with the circulation pump at 100 percent.The flowmeter impeller was bound tight and would not spin.Actual flow was confirmed through a shunt line although measured with a test flowmeter 1 lpm too low.Bypass flow was measured low as well.This was due to a failing circulation pump.The device will not heat due to a failed card cage power supply not providing heater relay voltage to the main ac power supply card.The device overfilled during decontamination.There was a lot of debris seen in the tank and in the level sensor fill tube that could have stopped water from entering the tube and into the fill sensor.Once cleared the device filled properly.It had an alarm 61 (non-recoverable system error) caused by faulty processor.
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Event Description
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It was reported that the arctic sun device was booting up to a red screen stating, that the device failed to start.Mss discussed that this was indicative of a loss of communication with the control panel.Biomed stated that they already replaced the isolation card and stated would rather try replacing other components from an arctic sun device and then would attempt to troubleshoot.Mss discussed the pathways and possible components with them.Biomed called back and stated that they would like to send the device in for repair.As per email response received on 06dec2021, biomed stated that there was no patient involvement, and the arctic sun device would be sent to the depot for repairs.As per sample evaluation result received on 25may2022, it was reported that the device booted up to a red screen.This was a combination of failed processor, power supply, and input output circuit cards in the card cage.Mss stated that the flow was reading zero with the circulation pump at 100 percent.The flowmeter impeller was bound tight and would not spin.Actual flow was confirmed through a shunt line although measured with a test flowmeter 1 lpm too low.Bypass flow was measured low as well.This was due to a failing circulation pump.The device will not heat due to a failed card cage power supply not providing heater relay voltage to the main ac power supply card.The device overfilled during decontamination.There was a lot of debris seen in the tank and in the level sensor fill tube that could have stopped water from entering the tube and into the fill sensor.Once cleared the device filled properly.It had an alarm 61 (non-recoverable system error) caused by faulty processor.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.
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Search Alerts/Recalls
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