Catalog Number 6252000000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2017 |
Event Type
malfunction
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Event Description
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It is alleged the chest strap was inserted into the buckle and would not release.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
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Manufacturer Narrative
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The issue was resolved for the customer by replacing the restraint strap set.
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Event Description
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It is alleged the chest strap was inserted into the buckle and would not release.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
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Manufacturer Narrative
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Supplemental submitted to include udi.
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Event Description
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It is alleged the chest strap was inserted into the buckle and would not release.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
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Search Alerts/Recalls
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