Catalog Number 4402000001 |
Device Problem
Inflation Problem (1310)
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Patient Problem
Physical Entrapment (2327)
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Event Date 05/15/2018 |
Event Type
malfunction
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Event Description
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It was reported that the bassinet mattress had overinflated due to being in the high altitude.The customer received 36 bassinets and all mattresses experienced the overinflation issue.Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet.No adverse consequence was reported.
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Manufacturer Narrative
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Stryker medical notified fda of field action (b)(4) on (b)(4) 2018.
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Event Description
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It was reported that the bassinet mattress had overinflated due to being in the high altitude.The customer received 36 bassinets and all mattresses experienced the overinflation issue.Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet.No adverse consequence was reported.
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Search Alerts/Recalls
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