The following manufacturer field safety notices or medical device alerts have been identified.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a field safety notice in April 2015 for the Vitalpac system, one of the 5 technologies assessed in this briefing. It reported that Vitalpac under-scored the EWS in Vitalpac V2.3 and V3.0, resulting in potential misclassification of deterioration risk. A product fix was delivered, and affected customers were also asked to review the case notes of patients at potential risk of harm. A notice in February 2016 reported that clients' servers sometimes rejected patient observation data submitted from Vitalpac Nurse V3.x, with the observations not appearing in patient charts and records. A product fix was delivered, and affected customers were also asked to review case notes of patients who were potentially affected.