Model Number IRC5PO2V |
Device Problems
Device Alarm System (1012); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available a supplemental record will be filed.
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Event Description
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The dealer stated the unit tested low purity.The dealer stated it did not alarm.
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Manufacturer Narrative
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Product was returned for evaluation.The return fields in oracle state: stationary concentrators.Sieve bed, saturated.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
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Event Description
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Product was returned for evaluation.The return fields in oracle state: stationary concentrators.Sieve bed, saturated.The dealer stated the unit tested low purity.The dealer stated it did not alarm.
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Search Alerts/Recalls
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