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Model Number 9004051 |
Device Problems
Break (1069); Unable to Obtain Readings (1516)
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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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Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found cracked bottom case.Functional testing confirmed reported problem.The root cause of the reported issue was found to be the rear sample line was cut right off; replaced the rear sample line.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 the device was not reading correctly and cable was cut off.No patient injury was reported.
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Search Alerts/Recalls
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