Catalog Number 4402000001 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Code Available (3191)
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Event Date 05/24/2018 |
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 9 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 9 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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