National Early Warning Score systems that alert to deteriorating adult patients in hospital

Regulatory information

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.