SV300 VENTILATOR
Received Aug 6, 2020 · Event occurred Jul 5, 2020
Report 3009156722-2020-00009 · MDR key 10372575
Device
Generic name
Sv300 Ventilator
Catalog number
EV20B-PA00188
Product problems
- Human-Device Interface Problem
- Human-Device Interface Problem
Patient
Not reported
- Sudden Cardiac Death
- Sudden Cardiac Death
Narrative
Additional Manufacturer Narrative
THE EVENT WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2020 AT 11:20AM. EVALUATION OF SYSTEM LOGS INDICATES A "TUBE DISCONNECTED?" ALARM WAS TRIGGERED AT 10:22 AND LASTED FOR 5 MINUTES. CONCURRENTLY, ALARMS FOR "APNEA" AND "MV TOO LOW" WERE TRIGGERED. ADDITIONAL ALARMS WERE TRIGGERED AND ALARMED CONTINUOUSLY FOR 10 MINUTES BETWEEN 11:17AM AND 11:27AM. DURING THIS PERIOD THE ONLY INTERACTION WITH THE SYSTEM WAS AN ADJUSTMENT TO THE RESPIRATOR RATE. THE ALARMS RESULTED FROM A SEPARATION/LEAK BETWEEN THE SAFETY VALVE ASSEMBLY AND THE SAFETY VALVE ASSEMBLY HAND WHEEL.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPIRED WHILE BEING VENTILATED ON A SV300 VENTILATOR. THE REPORTED EVENT OCCURRED IN (B)(6).