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Model Number AS480 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Root cause: potential alteration of staining in this case was due to improper operation of the dispense check valve (3 psi one way valve).The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following a dispense check valve malfunction, or if the part stops working.The resulting failure mode could occur.Small leak could result in drops of buffer from the probe after wash, or dispensing aberration resulting in low volume dispensed (first dispense).This failure mode has the potential to alter staining.
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Event Description
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Based on complaint report, or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows, "salt residue." no direct, or indirect patient harm, or user harm have been reported.
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Search Alerts/Recalls
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