Regulatory information

Regulatory information

VitalPAC was CE marked as a class 1 device in 2009. The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued the following manufacturer Field Safety Notices for this device:

  • In April 2015, a Field Safety Notice reported underscoring of early warning scores (EWS) in VitalPAC V2.3 and V3.0 resulting in possible misclassification of deterioration risk. All affected local users were advised to follow the recommended sequence of steps for vital sign recording and external monitoring, email alerting and daily monitoring reports were offered. A product fix was delivered to affected sites and sites were asked to carry out a case-note review of patients identified as being at possible risk of harm. No harm was reported and the case was subsequently closed.

  • In February 2016, a Field Safety Notice reported that clients' servers sometimes rejected VitalPAC data that had been submitted. On these occasions, VitalPAC behaved as expected, but the record was not saved. The 'observation due' clocks stayed unchanged on the patient lists, showing that the observations had not been sent and prompting nurses to resend the set of observations. Local users were advised to carry out a case-note review of patients who had been identified as possibly affected and report back any cases of actual harm. None were reported. A product correction fix was delivered and the case was subsequently closed.