Model Number 8400D |
Device Problems
Display or Visual Feedback Problem (1184); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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One unit was returned for investigation.There were lcd lines missing, with a lens crack and co2 pump was shifted.All these signs pointed towards the device suffering an impact such as a drop.Root cause traced to user.No dhr review done.
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Event Description
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It was reported that there was a broken lcd and calibration issues.
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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: 3012307300-2021-09699.The report was submitted in error.
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Search Alerts/Recalls
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