EVITA XL
Received Oct 30, 2020 · Event occurred Oct 8, 2020
Report 9611500-2020-00387 · MDR key 10762736
Device
Generic name
Ventilators, Intensive Care
Manufacturer
Drägerwerk Ag & Co. KgaaModel number
NACatalog number
8419600
Lot number
NA
Product problems
- Gas Output Problem
- Decrease in Pressure
- Data Problem
- Gas Output Problem
- Decrease in Pressure
- Data Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE WAS ANALYZED BY THE HOSPITALS BIOMED IN COMMUNICATION WITH THE DRÄGER TECHNICAL SUPPORT. THE LOG FILE CONFIRMS THAT THE DEVICE INITIATED MULTIPLE RESTARTS ON (B)(6) 2020 AT 10:01 PM DUE TO AN INTERNAL DEVIATION. THE DEVICE WAS IMMEDIATELY SWITCHED TO STANDBY BY THE USER AT 10:02 PM. THE ANALYSIS CONCLUDED THAT A FAULTY PCB PNEUMATIC CONTROLLER WAS THE ROOT CAUSE FOR THE ISSUE. THE DEVICE WAS REPAIRED BY REPLACING THE AFFECTED PCB. THE DEVICE REACTED AS SPECIFIED FOR THIS MALFUNCTION BY INITIATING A WARMSTART IN AN ATTEMPT TO SOLVE THE ISSUE. DURING A WARMSTART THE SCREEN IS SWITCHED TO DARK AND AN EMERGENCY-BREATHING VALVE OPENS TO ALLOW FOR SPONTANEOUS BREATHING. THIS IS ACCOMPANIED BY AN AUDIBLE ALARM. AFTER SUCCESSFULLY PERFORMING THE REBOOT (DURATION APPROX. 8 SECONDS) THE VENTILATION IS CONTINUED WITH THE LATEST PARAMETERS. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE SCREEN BLACKED OUT TWICE DURING PATIENT USE. THE DEVICE WAS REPLACED. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE SCREEN BLACKED OUT TWICE DURING PATIENT USE. THE DEVICE WAS REPLACED. NO PATIENT INJURY REPORTED.