The monitor was manufactured december 21, 2007 and review of the device history record supports that there were no non-conformances noted during the manufacturing of the referenced monitor.
Additionally, no prior service has been documented for this device.
Per edwards¿ procedures the useful life of the monitor is 5 years.
The referenced monitor has significantly exceeded its useful life.
The actual values, reported as ¿low,¿ were requested; however, the information was unable to be ascertained.
Examination of the returned device confirmed a faulty heart rate sensor; noting ¿air in hose.
¿ additionally, physical damage was detected on the front of the monitor and the ic net entry and switch required replacement.
The root cause of the issue was unable to be associated with any manufacturing defect.
The front monitor and ic net entry were replaced.
Unit testing was executed and calibration was performed for the monitor, wrist unit, ecg box and finger cuff.
All functional testing, as well as electrical safety testing, was successfully performed without any issues noted for any reason.
Edwards will continue to review and monitor all events.
If action is required, an appropriate investigation will be performed.
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