Model Number IHSC900DLX |
Device Problem
Material Integrity Problem (2978)
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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.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).No immediate risk noted with event to escalate to capa/crt.One serious injury noted out of all (b)(4) bed throughout a single business unit.Complaint data over a 2 year period did not show any similar issues or injuries with the (b)(4) bed.Conclusions of erb show that the underlying cause appears to be metal burs left after molding.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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Search Alerts/Recalls
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