Model Number 1635-10 |
Device Problem
Disconnection (1171)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that while attempting to remove the distal female tubing connector in order to connect the nebulizer, the entire hard tube came away from the mask.It was also reported that when the nebulizer is then inserted (into the mask) and the oxygen is turned on, the nebulizer is blown off of the mask continuously.This reportedly occurred more frequently in cold weather conditions.There was no patient harm reported as a result of the product issue.
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Manufacturer Narrative
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Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Note: there are seven (7) cases associated with this product; therefore a separate fda form 3500a has been generated to address the other six (6) cases.
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Manufacturer Narrative
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Additional information was received to clarify complaint details.The product was not requested for return since the product cannot be obtained.The customer does not require a response for the investigation findings.The number of affected products was one.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Manufacturer Narrative
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Additional information received: samples have not been received from the manufacturer.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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