Model Number IPN922891 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".Associated mdrs: 9681900-2022-00031 and 9681900-2022-00033.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Qn#(b)(4).Three lma proseal were returned from customer on ground of "the red cap of the manual vent is missing".There was no patient involvement in the incident.There was no returned usage record card listing the date of initial use of the devices till its last use.There was no invoice date and invoice number given for validity of warranty.The device was manufactured in 2019.The red plug cap of the device was observed broken at the first glance upon receipt.The reported failure was verified as the lma could not hold cuff inflation with the red plug cap damage /missing.The outer profile of the return complaint samples looks yellowish / discolored due to multiple reuses.The red plug and its cap were the same component produced in the same molding.In order to simulate the process of shutting and opening of the red plug cap, a retained sample was used.It was observed that the red plug cap will not be stressed when it was handled properly.Dhr was reviewed.No abnormality was found.The customer is reminded that lma reusable is made of soft silicone rubber.It should be handled with care for re-using it and it is not supposed to hold the body weight of the device with the red plug cap itself.In addition, in case the red plug cap of the device was tangled with other objects, try not to use abrupt force to pull it.The root cause of the failure concluded as method of use related.
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Event Description
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It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".See associated mdrs 9681900-2022-00031 and 9681900-2022-00033.
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Search Alerts/Recalls
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