SAVINA

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A POWER FAIL ALARM DURING USE AND SHUT DOWN. THE PATIENT WAS IMMEDIATELY CONNECTED TO ANOTHER DEVICE; NO PATIENT CONSEQUENCES HAVE REPORTEDLY OCCURRED.

Additional Manufacturer Narrative

THE EVENT DATES BACK TO (B)(6) 2021 AND, THE USER FACILITY DID NOT INVOLVE THE LOCAL DRÄGER S&S ORGANIZATION IN EXAMINATION AND REPAIR OF THE DEVICE THAT TIME. THE DEVICE IS NOT UNDER A SERVICE CONTRACT; THE HOSPITAL PERFORMS PREVENTIVE MAINTENANCE AND REPAIRS ON OWN BEHALF AND RESPONSIBILITY. UPON RECEPT OF THE USER FACILITY REPORT, DRÄGER WAS CONTACTING THE HOSPITAL TO OBTAIN FURTHER INFORMATION. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED BY A HOSPITAL TECHNICIAN WHO FOUND A LOT OF DUST INSIDE THE UNIT AND THUS, CAME TO THE CONCLUSION THAT OVERHEATING OF ELECTRONIC PARTS HAS LED TO SHORT CIRCUIT IN THE POWER SUPPLY. THIS RESULTED IN THE UNEXPECTED SHUTDOWN THEN. DRÄGER FINALLY CONCLUDES THAT THE LIKELY ROOT CAUSE FOR THE REPORTED EVENT WAS LACK OF PREVENTIVE MAINTENANCE. THE DEVICE HAS RESPONDED AS DESIGNED UPON THE POWER SUPPLY MALFUNCTION AND ALERTED THE USER BY MEANS OF A CORRESPONDING ACOUSTICAL ALARM WHICH IS BUFFERED BY AN INDEPENDENT POWER SOURCE. NO PATIENT CONSEQUENCES HAVE OCCURRED.