Model Number IHSC900DLX |
Device Problem
Scratched Material (3020)
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Patient Problem
Injury (2348)
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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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The dealer originally contacted us regarding a serious injury alleged, and after further inspection of an audit across all of their homes, they noticed that this edge was on all of the beds was ranging from a little roughness on the edge to a razor sharp corner.They had to have their maintenance directors go around and file each one down to avoid any future incidents.
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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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The dealer originally contacted us regarding a serious injury alleged, and after further inspection of an audit across all of their homes, they noticed that this edge was on all of the beds was ranging from a little roughness on the edge to a razor sharp corner.They had to have their maintenance directors go around and file each one down to avoid any future incidents.
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Search Alerts/Recalls
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