Catalog Number 401622 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that an unspecified number of anesthesia, 17gax18cm durasafe, experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: on november 5th, the customer reported to the distributor that 5 anesthesia had different problems in the near future, and they filed complaints, including damaged inner packaging, missing parts inside, and blocked filter discs.
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Event Description
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It was reported that an unspecified number of anesthesia 17gax18cm durasafe experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: on (b)(6) the customer reported to the distributor that 5 anesthesia had different problems in the near future, and they filed complaints, including damaged inner packaging, missing parts inside, and blocked filter discs.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9261486.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Search Alerts/Recalls
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