MAUDE MDR 9907652

MDR report key
9907652
Report number
9611500-2020-00108
Event key
0
Event type
3
Date of event
2019-12-12
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EVITA XLVENTILATORS, INTENSIVE CAREDR?GERWERK AG & CO. KGAACBKNA8419600NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

FOR THE INVESTIGATION THE GIVEN INFORMATION WERE ANALYSED. IT WAS ASSUMED THAT DUE TO A FAULTY NON-RETURN VALVE THE EVITA XL PERFORMED ONE OR SEVERAL WARMSTARTS IN ORDER TO SOLVE THE DETECTED PROBLEM. I SUCH A CASE THE EVITA XL ALERTS THE USER SEVERAL TIMES ABOUT THE VENTILATION SITUATION. AS A SAFETY FEATURE OF THE VENTILATOR, THE VENTILATOR SOFTWARE ANALYZES AND VERIFIES PROPER FUNCTION OF THE DEVICE. IT IS LIKELY THAT THE VENTILATOR SOFTWARE DETECTED AN INTERNAL FAILURE. THE USER WOULD BE ALERTED TO THIS CONDITION BY AN AUDIBLE ALARM AND A VISUAL MESSAGE WOULD BE POSTED IN THE DISPLAY. THE VENTILATOR MAY ATTEMPT A WARMSTART (TO RE-BOOT). AN AUDIBLE ALARM WOULD BE POSTED BY THE DEVICE AND WHEN THE WARM START OCCURS, THE DEVICE WILL BRIEFLY POWER OFF AND THEN BACK ON. DURING THIS TIME, AN EMERGENCY-BREATHING VALVE WOULD OPEN ALLOWING FOR SPONTANEOUS BREATHING. IN THE EVENT OF AN UNSUCCESSFUL WARM START, A CONTINUOUS AUDIBLE ALARM WOULD BE ACTIVATED, AND THE EMERGENCY-BREATHING VALVE WOULD REMAIN OPEN ALLOWING FOR SPONTANEOUS BREATHING. MANUAL VENTILATION WITH AN ALTERNATE DEVICE MAY BE CONSIDERED NECESSARY. (REMARK: A SINGLE SUCCESSFUL WARMSTART LASTS APPROXIMATELY 8 SECONDS.) THE EVITA XL WAS REPAIRED ON SITE BY REPLACING THE SUSPECTED NON-RETURN VALVE. IT REMAINS UNCLEAR, WHICH NON-RETURN VALVE EXACTLY WAS REPLACED. HOWEVER, NO FURTHER PROBLEMS WERE REPORTED UP TO NOW. IT REACTED AS SPECIFIED FOR THIS FAILURE CONDITION.

D

Patient 1

IT WAS REPORTED THAT THE UNIT WAS ALARMING VENT INOP. THERE WAS NO PATIENT INJURY REPORTED.