Operator of device and initial reporter sent to fda are unknown; no additional information was received.The device was returned for first-time service and evaluation after 2 years in the field.The strain relief section of the ear probe was found damaged.Investigation determined that the strain relief device connection end of the spo2 probe was torn and open internal wires connection were detected.The open wires resulted from torn strain relief at the probe connection end due to cord being subject to heavy use with extraneous forces.Instructions for use (ifus) indicate that "misuse or improper handling can damage the sensor or the cable.This may cause inaccurate readings.Do not twist unnecessarily or use excessive force when using, connecting, disconnecting, or storing the sensor." the failure resulted from malfunctioning spo2 probe due to broken internal wire connection.Root cause was deemed to be user interface.A device history record (dhr) review is not applicable in this case because the defective spo2 probe is not evaluated or tested in any way during the manufacturing process and the spo2 probe manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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