INOMAX DSIR (DELIVERY SYSTEM)
Received Apr 3, 2014
Report 3004531588-2014-00010 · MDR key 3880036
Product problems
- No Display/Image
- Device Inoperable
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS INITIAL NON-SERIOUS DEVICE CASE REPORT WAS RECEIVED ON (B)(6) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO CALLED TO REPORT A "FAULTY DISPLAY SCREEN" ON THE INOMAX DSIR DS20090537. THE DEVICE WAS NOT IN USE AT THE TIME OF THE DEVICE ISSUE. (COMPLAINT-(B)(4)). INVESTIGATION RESULTS COMPLETED ON (B)(4) 2014. CASE COMMENT: (B)(4) 2014: THIS DEVICE WAS NOT IN USE AT THE TIME OF DEVICE MALFUNCTION AND DID NOT RESULT IN AN ADVERSE EVENT; HOWEVER IT IS BEING REPORTED BECAUSE A SIMILAR MALFUNCTION OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (SEE MDR#3004531588-2013-00023). EVALUATION SUMMARY: THE INOMAX DSIR DS20090537 WAS RETURNED TO IKARIA'S REGIONAL SERVICE CENTER (RSC) FOR SERVICE EVALUATION. THE RSC INVESTIGATION CONFIRMED AND EXPERIENCED THE REPORTED COMPLAINT OF DISPLAY GOING BLANK. THE RSC REPLACED THE DISPLAY, SHROUD, AND BACKLIGHT INVERTER TO CORRECT THE PROBLEM. THE ROOT CAUSE FOR THIS INCIDENT IS DISPLAY - BACKLIGHT FAILURE.
Description of Event or Problem
TOUCH SCREEN ON THE INOMAX DSIR BLANK AND NOT RESPONDING [DEVICE MALFUNCTION]. CASE DESCRIPTION: THIS INITIAL NON-SERIOUS DEVICE CASE REPORT WAS RECEIVED ON (B)(6) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO CALLED TO REPORT A "FAULTY DISPLAY SCREEN" ON THE INOMAX DSIR DS20090537. THE DEVICE WAS NOT IN USE AT THE TIME OF THE DEVICE ISSUE. IKARIA INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2014. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: NO PATIENT. CONCOMITANT MEDICATIONS: NOT APPLICABLE. ACCORDING TO THE RT, ON (B)(6) 2014 "UPON START UP, THE MAIN SCREEN OF THE INOMAX DSIR DS 20090537 APPEARED FOR A FEW SECONDS THEN BURNED BLANK/BLACK." THE RT STATED THERE WAS "SLIGHT BACKLIGHT TO THE SCREEN MAKING IT ALMOST APPEAR PINK IN COLOR". THE RT CYCLED THE AC POWER TO STANDBY THEN ON HOWEVER THE TOUCH SCREEN ON THE INOMAX DSIR WAS NOT RESPONDING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE DEVICE ISSUE. THE INOMAX DSIR DS20090537 WAS RETURNED TO IKARIA FOR INSPECTION.