Model Number SC900-80WDLX-QSP |
Device Problem
Scratched Material (3020)
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Patient Problem
No Information (3190)
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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.Reference report number 1031452-2016-01663 for serious injury previously reported.
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Event Description
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Customer alleged the replacement bed, they received had arrived with sharp like edges.
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Manufacturer Narrative
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(b)(4) created for this event.(b)(4) created to resolve issue.No immediate risk noted with event to escalate to capa/crt.One serious injury noted out of all 172 bed throughout a single business unit.Complaint data over a 2 year period did not show any similar issues or injuries with the ihsc900dlx bed.Conclusions of erb show that the underlying cause appears to be metal burs left after molding.Reference report number 1031452-2016-01663 for serious injury previously reported.
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Event Description
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Customer alleged the replacement bed they received had arrived with sharp like edges.
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Search Alerts/Recalls
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