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Model Number MX4810 |
Device Problems
Increase in Pressure (1491); Pressure Problem (3012)
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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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During investigation the visual inspection confirmed that: the gauge is in zero position and the product was assembled as per drawing specification.Also the functional test was performed on both samples.Product was inflated to 300mm hg and the c-fusor kept the pressure for 2 minutes.After the functional test the gauge dropped to zero position as expected.No fault found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Event Description
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It was reported that device is reading very high pressure, another device is reading very low.Devices failed during testing straight out of the box, no patient involvement.
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Search Alerts/Recalls
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