TOSCA 500 USA

Additional Manufacturer Narrative

THE MONITOR TEMPERATURE WAS NOTED AT 44 DEGREES CELSIUS. THE USER MANUAL FOR THE TOSCA 500 STATES A RECOMMENDED TEMPERATURE OF 42 DEGREES CELSIUS AND A MAXIMUM TEMPERATURE OF 44 DEGREES CELSIUS. THE CUSTOMER EXPLAINED THAT THIS MONITOR WAS USED FOR SLEEP STUDIES THAT CAN LAST UP TO 10 HOURS, AND THAT THE SITE TIME WAS SET AT 9 HOURS. HOWEVER, THE USER MANUAL FOR TOSCA 500 INSTRUCTS A MAXIMUM SITE TIME OF 4 HOURS WHEN SETTING THE TEMPERATURE AT 44 DEGREES CELSIUS. THE PROLONGED SITE TIME AT THE HIGH TEMPERATURE INDICATES THAT THE EVENT WAS CAUSED BY A USER ERROR.

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

IN THE INITIAL REPORT ADVERSE EVENT WAS CHECKED BUT IT WAS NOT AN ADVERSE EVENT BUT A MALFUNCTION DUE TO A USE ERROR WHY NO MDR SHOULD HAVE BEEN FILED. SERIOUS INJURY SHOULD HAVE BEEN LEFT BLANK IN INITIAL REPORT. INITIAL REPORT: THE COVER LETTER STATES "...FOR A SERIOUS INJURY INVOLVING CLINITUBES". THE CASE CONCERNS TCM TOSCA 500 SENSOR 92, SO THE CORRECT STATEMENT IS "...FOR A SERIOUS INJURY INVOLVING TCM TOSCA 500 SENSOR 92".