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Device Problem
Defective Device (2588)
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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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Initial reporter also sent report to fda?: yes, medwatch mw5107253.No product sample was received; therefore, visual and functional testing could not be performed and root cause could not be determined.No lot number was provided; therefore, a device history record (dhr) review could not be completed.
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Event Description
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It was reported that the cassettes were defective.The cassettes were replaced and the issue resolved.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-06030.The report was submitted in error.
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Search Alerts/Recalls
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