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Model Number MX9505T |
Device Problems
Unable to Obtain Readings (1516); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4) as a result of warning letter cms# 617147.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.
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Event Description
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It was reported that the connection line and the transducer that measures blood pressure were not working.The patient's arterial blood pressure could not be monitored.No patient injury was reported.
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Search Alerts/Recalls
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