Model Number 100/897/080 |
Device Problem
Break (1069)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 02/07/2022 |
Event Type
Injury
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Event Description
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It was reported that the inner cannula partially dislodged and unable to be secured into place despite re-attempts.Patient became unstable, desaturating to 70s.Patient required ambu-bagging and dr.Returned to the bedside.Dr.Performed a bronch/tracheostomy swap and removed the old trach.The old trach is visibly broken/defective with potential to become dislodged and descend further into the patients airway.There was no patient injury reported.
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Manufacturer Narrative
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One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
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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# 617147.A product sample was received for evaluation.Visual testing was performed.Under visual inspection we noticed that white connector is separated from tube as described by customer.Condition of returned sample indicates poor user handling.The connector is very badly scratched around its whole diameter.It is not possible that connector left manufacturing site in such conditions.Connectors are manually bonded with tracheostomy tube as per manufacturing procedure with the help of solvent.Within this manufacturing process, there are several quality checks implemented for visual and functional inspection.The returned sample was inspected under magnification and presence of solvent was confirmed.Complaint history was checked and no trend of confirmed customer complaints were identified.Based on poor condition of connector this claim is considered to be user issue caused by poor handling with product.
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Search Alerts/Recalls
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