INOMAX DSIR (DELIVERY SYSTEM)

Additional Manufacturer Narrative

UPON INTERNAL REVIEW ON (B)(4) 2014, IT WAS DETERMINED THIS DEVICE COMPLAINT REQUIRES REPORTING ((B)(4)). DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. CASE COMMENT: ON (B)(4) 2014: THIS DEVICE CASE DID NOT RESULT IN AN ADVERSE EVENT, HOWEVER IT IS BEING REPORTED BECAUSE A SIMILAR DEVICE ISSUE OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (REFER TO MDR #3004531588-2013-00023). EVAL SUMMARY: INOMAX DSIR DS20101099 WAS RETURNED TO THE MFR FOR SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOG AND CONFIRMED THE REPORTED COMPLAINT-DISPLAY GOES BLANK. THE SERVICE LOG REVEALED THE DELIVERY FAILURE (DF) ALARMS DUE TO BACKLIGHT CURRENT BELOW MINIMUM. (MINIMUM: 800 COUNTS ACTUAL VALUE: 624 COUNTS CONSISTENT WITH FAILING DISPLAY). RSC INVESTIGATION DID NOT REVEAL A BLACKED OUT AREA BUT DID EXPERIENCE A PINKISH/RED COLOR. THE INVERTER BOARD AND THE DISPLAY WERE REPLACED. THE ROOT CAUSE FOR THIS INCIDENT IS DISPLAY BLANK-BACKLIGHT FAILURE. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THIS DEVICE CASE DID NOT RESULT IN AN ADVERSE EVENT, HOWEVER IT IS BEING REPORTED BECAUSE A SIMILAR DEVICE ISSUE OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (REFER TO MDR #3004531588-2013-00023).

Description of Event or Problem

DISPLAY ISSUE - DEVICE SCREEN WAS NOT FUNCTIONING PROPERLY [DEVICE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: UPON INTERNAL REVIEW ON (B)(6) 2014, IT WAS DETERMINED THIS DEVICE COMPLAINT REQUIRES REPORTING. ON (B)(6) 2014, A RESPIRATORY THERAPIST (RT) CALLED TO SPEAK WITH IKARIA TECHNICAL SERVICES REGARDING A DEVICE ISSUE WITH INOMAX DSIR DS20101099. THE RT REPORTED SECOND HAND THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY. IT WAS ALSO REPORTED THAT WHERE THE NITRIC OXIDE VALUE WAS NORMALLY DISPLAYED WAS BLACKED OUT THEREBY MAKING IT IMPOSSIBLE TO READ WHAT CONCENTRATION OF NITRIC OXIDE THE PT WAS RECEIVING. IT WAS STATED THAT ALL OTHER MENTIONED VALUES WERE VISIBLE. THE DEVICE HAS BEEN REMOVED FROM SERVICE AND REPLACED WITH A BACKUP DEVICE. THE RT STATED THERE WAS NO PT INJURY OR DETERIORATION IN A PT'S HEALTH WITH THE REPORTED DEVICE ISSUE. INOMAX DSIR DS20101099 WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVAL.