Model Number 724200 |
Device Problem
Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2022 |
Event Type
malfunction
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Event Description
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The customer reported the probes balloon leaked during use.It was necessary to exchange the probe.
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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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Manufacturer Narrative
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Additional information: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed because no photo or sample was available for evaluation.Based on the present information, a root cause cannot be determined.Based on the historical review, a corrective and preventative action (capa) was generated to the supplier to further investigate this issue.This complaint will be used for tracking and trending purposes.
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Manufacturer Narrative
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Additional information: h4 device manufacture date was added the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.One sample was received for the evaluation.A visual inspection and functional testing were performed.The balloon was inflated with water and a leak was detected.A corrective and preventative action (capa) was opened to further investigate this issue.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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