During the investigation the monitor came in for? co2 reading really high? the customers comments are verified.The flowrate was checked, and it read 134 ml/min (spec 150+/-+20 ml/min).Applied 10% gas and got 100 and the barometric pressure for the day is 74.0 mmhg so it was way out of spec, then a lo cal was performed and got 100, then a hi/lo calibration was performed and read 72.0 mmhg (spec 74 mmhg+/-3) which is in spec for the day's pressure.The customer should make sure they are using the bci cal gas, the kit # is 8217 if you need to order.If the customer is using the wrong gas, they can get number like this and will happen again due to this monitor is supposed to have a hi/lo calibration every 6 months.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
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