Complaint evaluation: the device was not returned for evaluation.The field service engineer (fse) assessed the situation remotely on (b)(6) 2019.Under the direction of the fse, the ces performed a clinical audit trail and noted no inops for spo2 which are not logged.The fse also had the ces check to see if a silence occurred or if there was a logging of measurement being turned off and there were none identified.The ces checked the event review and no technical items were noted for spo2 off.The fse remoted into the customer's system and performed a clinical audit, seeing the same data as the ces, and noted an alarm silence at 1427 hours (2:27 pm) with no associated yellow or red alarm performed by (b)(4) which may have been for an inop.Due to two days passing, the fse was not able to further verify at bedside if an inop alarm occurred or if silenced.The clinical audit showed yellow spo2 alarm at 15:27:29 hours (3:27 pm) followed by red spo2 [desat] at 15:27:39 hours (3:27 pm seconds later).Additionally, the nurse said there was no alarm for the probe being off the finger.The fse did a clinical audit remotely and said there was an alarm silenced at about the time the probe was off.The cause of the event remains unknown.The patient continued with monitoring as of (b)(6) 2019 and the device remained at the customer site.
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