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Model Number ER400-9 |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected at a distance of 12" to 24" in normal conditions of illumination.The failure couldn't be reproduced.The root cause of the reported issue was found to be material in the seal.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that before opening the package, the customer confirmed the product and a different product were in the same package.No patient injury or involvement was reported.
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Search Alerts/Recalls
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