Model Number 7-5105 |
Device Problem
Moisture Damage (1405)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Moisture causing them to get stuck so, they would break apart or must be thrown out.The adapter is a component of a ventilator circuit and the incident occurred during use.Base on the reported information the criteria for reporting an adverse event has been met.
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Event Description
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Moisture causing them to get stuck, so they would break apart or have to be thrown out.
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Event Description
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Moisture causing them to get stuck so they would break apart or have to be thrown out.
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Manufacturer Narrative
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Moisture causing them to get stuck so they would break apart or must be thrown out.The adapter is a component of a ventilator circuit and the incident occurred during use.Base on the reported information the criteria for reporting an adverse event has been met.Complaint confirmed via testing of lot# 010422u26.22mm od side of adaptor is not iso spec, but actually 0.875" as noted on drawing 24011.Ncmr-02278 has been opened to address molding issues.Customer informed of nonconformance.Issue has been sent for carb review due to loss of intended function from being out of tolerance.
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Search Alerts/Recalls
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