Model Number 3773MM |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/28/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacture date: 07/2014.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.Additional patient/event details have been requested; however, 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 were reportedly 15 devices affected by this issue.A separate fda form 3500a or its electronic equivalent has been submitted for each case.(b)(4).
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Event Description
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It was reported the "when the nurse connected the product with the oxygen tube and wanted to start the treatment of the patient, the mask did not nebulize".It was further reported that "it makes a wheezing sound and no "dust" comes out like normally".
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Manufacturer Narrative
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Previous investigation leveraged for this complain and the investigation is completed.Two root causes were identified: the jet was being produced in an old injection molding machine that was not conditioned with an alarm to detect and prevent the variation (double cycle) in the process.This machine has been discontinued; inadequate inspection process for nebulizers.Corrective action has been implemented to include: verifying all active molding machines to confirm all have integrated the required alarms; create a temporary quality alert to inspect nebulizer components every 2 hours as our inspection process is updated; creation of a test method for inspection of molded components (nebulizer set and jet); create a test method for inspection of molded components; clarify all details of process to do the mixing and add a form to record the amount of resin and material used in each mixing; determine water flow rates, water temperature and pressure, and include process parameters to be monitored; determined the expected shelf life of pins for the orifice of cup and jet, and establish its replacement in the adequate period of time.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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A quality investigation was performed along with a batch review.Examination of batch records indicated the product was manufactured according to specification.No discrepancies were found.Although there is not enough information to conclude the product did not meet specification and perform as intended, there is a previous investigation that is applicable for the type of nebulizer issues reported in the current complaint.The previous investigation is still pending; therefore, this complaint will remain open until completion of the investigation.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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