DeathBZK
GAS MODULE 3
Received Mar 26, 2020 · Event occurred Feb 21, 2020
Report 3009156722-2020-00006 · MDR key 9886524
Device
Generic name
Gas Module
Catalog number
0998-00-1900-01
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
7 YR
- Sudden Cardiac Death
- Sudden Cardiac Death
Narrative
Additional Manufacturer Narrative
THE USER FACILITY REQUESTED AN EVALUATION OF THE EQUIPMENT; NO MALFUNCTION OF THE EQUIPMENT WAS CLAIMED. THE RESULTS OF THE EVALUATION DETERMINED THE GAS MODULE REQUIRED N2O CALIBRATION ONLY.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT MONITORED ON A PASSPORT 2 MONITOR AND GAS MODULE WAS HAVING SURGERY AND ONE MINUTE INTO THE PROCEDURE THE PATIENT'S HEART STOPPED; THE PATIENT LATER EXPIRED.