The device was returned undamaged for evaluation.Failed relief pressure check for the 60 threshold setting was performed.Pressure relieved at 75, which is above the 48-66 spec.The alarm reed was replaced and now the pressure relieves at 55, which is within specification.The reported issue of relief pressure setting is relieving too high is confirmed.The root cause was determined as a faulty alarm reed.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 b10009406, as a result of warning letter cms# (b)(4).
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