This monitor returned to service about 2 years later with missing holding pads causing the spo2 board to loose.With the tamper seal not applied to the monitor at the time of manufacturing, unable to determine whether these missed during manufacturing or from customer tampering with the unit.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.Operator of device is unknown.No information provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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