Model Number 100/899/080CZ |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation of the complaint was limited because no sample was returned.Similar customer complaints where the same issues related to uniperc flange locking mechanism were raised in past and therefore (b)(4) was raised.
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Event Description
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It was reported that the latch to unlock the removable collar on this product opened overnight while the patient was sleeping, dislodging the length and making the tube mobile in the patient's trachea.The latch allowing this locking/unlocking of the collar is considered too soft by the customer.The patient would have been admitted to the emergency room.
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Manufacturer Narrative
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The investigation of the complaint was limited because no sample was returned.Similar customer complaints where the same issues related to uniperc flange locking mechanism were raised in past and therefore (b)(4) was raised.
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Event Description
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It was reported that the latch to unlock the removable collar on this product opened overnight while the patient was sleeping, dislodging the length and making the tube mobile in the patient's trachea.The latch allowing this locking/unlocking of the collar is considered too soft by the customer.The patient would have been admitted to the emergency room.
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Search Alerts/Recalls
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