The complaint device was returned for evaluation.Incoming visual inspection found that the case was chipped and the frame was cracked.Device evaluation identified an nibp malfunction.The nibp pump was replaced with a refurbished unit.The unit was calibrated.The front and rear connectors were inspected.The case was checked for damage.Diagnostics were ran.The ibp, nibp, shake test, spo2, temp test and final visual inspection all passed.The root cause was determined to be a leak in the nibp; however, it was not determined how this occurred.This type of event will continue to be monitored.It should be noted that this is being filed based on retrospective review.
|