SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Model Number 101/870/075CZ |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Event Description
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It was reported that the customer replaced the product with a new one in the morning and it worked properly for a while.In the afternoon however, he noticed cuff's air pressure would not go up.No patient injury.
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Manufacturer Narrative
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Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated as the inflation was detached from the pilot balloon.Dhr review was done, no issues related to the original complaint were found.
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Manufacturer Narrative
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Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source is manufacturing.Dhr review was done, no issues related to the original complaint were found.
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