Catalog Number 100/506/050 |
Device Problem
Component(s), broken (1103)
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Patient Problems
Bradycardia (1751); Therapy/non-surgical treatment, additional (2519); Hospitalization required (2580)
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Event Type
Injury
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Event Description
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Distributor reported on behalf of use facility that the device was in use with a home-care patient when they were hospitalized for bradycardia.After arriving at the hospital, a clinician was inspecting the tracheostomy tube when they found that it had collapsed.An emergent tracheostomy tube change was performed.Following the procedure, the patient's condition improved and they were discharged on (b)(6) 2014.No permanent adverse effects to the patient were reported.
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Manufacturer Narrative
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Manufacturer completed the entire form.Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.The actual device involved was returned and is currently in transit to the investigation site.
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Search Alerts/Recalls
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