Catalog Number RTLR180343 |
Device Problem
Sparking (2595)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be filed upon completion of the manufacturer's investigation.Evaluation in progress, not yet complete.
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Event Description
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A peritoneal dialysis patient reported that upon powering on the cycler, the power outlet emitted sparks.The patient confirmed that the house breakers were then the reset.At this point, the cycler would not power on.The power cord was secured at both ends.The patient was not connected to the cycler.The patient completed treatment with manuals.The cycler was replaced.
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Manufacturer Narrative
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Device evaluation: the actual device was returned for investigation.The visual exterior inspection showed no physical damage.The cycler turned on successfully and operated as intended.The cycler passed the voltage verification check.The cycler passed the 1000ml treatment.An internal visual inspection of the returned cycler encountered no discrepancies.The device history record did not reveal any issues or problems related to the reported symptom code(s).There were no non-conformance's found.
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Event Description
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A peritoneal dialysis patient reported that upon powering on the cycler, the power outlet emitted sparks.The patient confirmed that the house breakers were then the reset.At this point, the cycler would not power on.The power cord was secured at both ends.The patient was not connected to the cycler.The patient completed treatment with manuals.The cycler was replaced.
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Search Alerts/Recalls
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