Model Number AF5140MB |
Device Problem
Inflation Problem (1310)
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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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No event date was provide as well as no picture or product returned.Inventory evaluation of product did not confirm complaint.Investigation is inconclusive.
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Event Description
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The customer alleges the "air mask cannot be inflated." no other details were provided and no patient injury/harm reported.
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Event Description
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The customer alleges the "air mask cannot be inflated." no other details were provided and no patient injury/harm reported.
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Manufacturer Narrative
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One of the affected devices where returned.The mask valve functioned as intended when an inflation bulb was used.The mask was inflated and had no leakage.Complaint could not be confirmed.
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Search Alerts/Recalls
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