Model Number 720250 |
Device Problems
Fluid/Blood Leak (1250); Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported the product leaked and it was necessary to remove it from the patient.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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Additional information received dec.18, 2023 stated the balloon was leaking.
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Manufacturer Narrative
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H4 device manufacture date was added.The device history record (dhr) was reviewed showing that manufacturing and inspection of the product were performed as per applicable procedures and validated process.A sample analysis could not be performed because no photo or sample was available for evaluation.The reported condition could not be confirmed.The affected component is produced by an external supplier.Due to similar cases presented in the past, actions will be documented through a supplier corrective and preventative action.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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