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Model Number 100/541/080CZ |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2022 |
Event Type
malfunction
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Event Description
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It was reported the device was leaking.No patient injury was reported.
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Manufacturer Narrative
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Device evaluation (02/18/2022): one used decontaminated sample was returned for investigation without its original packaging (see photo of sample).Under visual inspection the sample appeared to be in good condition.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Inflation test was repeated on returned sample.It was found that it is not possible to inflate cuff because it leaks so badly.Three tears in cuff were observed (see photo of defect).Each cuff shall be also tested by customer prior use as per instruction for use as10001115-002 rev.100, preparation of components section, point 1: "check the tracheostomy tube cuff (cuffed tube only) by test inflation." due to fact that cuff leak was observed after placement (customer stated that it was happened during removal/at end of therapy) it is the most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use as10001115-002 rev.100, precautions, point 6: "guard against cuff damage by avoiding contact with sharp edges".The root cause was traced to the user manipulation of the device.No trend of confirmed complaints in relation with this issue was identified.
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Manufacturer Narrative
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Device evaluation (02/18/2022): one used decontaminated sample was returned for investigation without its original packaging (see photo of sample).Under visual inspection the sample appeared to be in good condition.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Inflation test was repeated on returned sample.It was found that it is not possible to inflate cuff because it leaks so badly.Three tears in cuff were observed (see photo of defect).Each cuff shall be also tested by customer prior use as per instruction for use as10001115-002 rev.100, preparation of components section, point 1: "check the tracheostomy tube cuff (cuffed tube only) by test inflation." due to fact that cuff leak was observed after placement (customer stated that it was happened during removal/at end of therapy) it is the most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use as10001115-002 rev.100, precautions, point 6: "guard against cuff damage by avoiding contact with sharp edges".The root cause was traced to the user manipulation of the device.No trend of confirmed complaints in relation with this issue was identified.
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Event Description
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It was reported the device was leaking.No patient injury was reported.
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Search Alerts/Recalls
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