Model Number 101/860/090CZ |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.It was found to be a supplied item fault.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
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Event Description
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It was reported that during the use of the product, the inflation line got detached from the pilot balloon.No patient injury.No additional information is available for this complaint.
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review one used decontaminated sample was returned for investigation without its original packaging.Under visual inspection we noticed that inflation line was detached from pilot balloon.Product was assembled in tijuana's manufacturing therefore secondary investigation object was created with purpose to capture component investigation.Similar customer complaints have been recently received therefore internal non-conformity report ncr was created with purpose to evaluate this issue.Tijuana's manufacturing site confirmed that no more physical complaint samples were needed for investigation therefore sample were kept in czech republic.No product was returned for second investigation; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Similar customer complaints have been recently received therefore internal non-conformity report corrective and preventive action (capa) was created with purpose to evaluate this issue.
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Search Alerts/Recalls
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