Model Number 6379 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Per field service representative (fsr) the flow would intermittently be displayed and then just read.00 flow.The unit has reached its end of service life and replacement parts are no longer available.The user facility has been advised to remove the unit from clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the unit was not reading a flow.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint has been confirmed.During laboratory analysis, the product surveillance technician (pst) observed there to be no flow readings due to a corroded cable connector on the internal flow meter.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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