Model Number FT19JN40NGE162N |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
Insufficient Information (4580)
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Event Type
Death
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Manufacturer Narrative
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B3: date of event; d4: expiration date and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that right after opening and using a custom trach, there were issues with the cuff not retaining water.While in the hospital it was discovered that there was a hole in the cuff.It was noted that the patient can "tolerate the trach uncuffed/deflated".The reporter mentioned that this occurred another time as well.No adverse effects reported.
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Event Description
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Additional information received via email.It was stated that the patient passed away in may.Medical assessment (b)(6) 2024: as reported the original complaints were related to the description of cuff deflation of a custom bivona tube.The manufacturer reached out several times since the initial report in (b)(6) 2023 with the last contact in (b)(6) 2023.It is reported that the parents did not want to answer any additional questions related to the event because the patient passed away in (b)(6) 2023.There is no information about the cause of the patient's death and no further information can be obtained from the complainant.Lack of details regarding this clinical event precludes a comprehensive medical assessment.Based on a review of the events in this case the cumulative evidence of this incident, it appears to exclude the bivona custom tubes as the cause of the patient event because it was reported that the patient tolerated the tracheostomy tube uncuffed and deflated from (b)(6) 2023 until her passing.Patient death is reported.If additional information becomes available, this medical assessment will be further revised.
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Manufacturer Narrative
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Other, other text: b1, b2: month and year have been provided, day is unknown., b5, h1 and h6 health impact; updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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