INOMAX DSIR (DELIVERY SYSTEM)
Received Jul 16, 2014
Report 3004531588-2014-00031 · MDR key 4013965
Product problems
- Failure to Sense
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
FAILED NO SENSOR [DEVICE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. 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 EMAILED IKARIA CUSTOMER CARE REGARDING A DEVICE ISSUE WITH INOMAX DSIR NUMBER (B)(4). THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE DEVICE ISSUE. IT WAS REPORTED THAT THE RT WAS UNABLE TO SPEAK WITH TECHNICAL SUPPORT (TS) NOR ABLE TO TROUBLESHOOT DEVICE AT TIME OF REPORT. INOMAX DSIR NUMBER (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION. INVESTIGATIONAL RESULTS WERE RECEIVED ON (B)(6) 2014.
Additional Manufacturer Narrative
ON (B)(6) 2014, A RESPIRATORY THERAPIST (PT) EMAILED IKARIA CUSTOMER CARE REGARDING A DEVICE ISSUE WITH INOMAX DSIR NUMBER (B)(4). THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE DEVICE ISSUE. IT WAS REPORTED THAT THE RT REFUSED TO SPEAK WITH TECHNICAL SUPPORT (TS) AND WAS NOT WILLING TO TROUBLESHOOT. ((B)(4)). DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. EVALUATION SUMMARY: INOMAX DSIR NUMBER (B)(6) WAS RETURNED TO THE MANUFACTURER FRO SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOG AND FINDINGS CONFIRMED THE REPORTED COMPLAINT OF A FAILED NO SENSOR ALARM AND WAS IMMEDIATELY PRECEDED BY A FAILED LOW NO CELL CALIBRATION WITH LOW POINT: 1784 COUNTS ABOVE THE ALLOWED MAXIMUM OF 655. THE RSC INVESTIGATION EXPERIENCED THE REPORTED COMPLAINT OF A FAILED NO SENSOR ALARM AT BOOTUP, CLEARED THE ALARM BY PERFORMING HIGH AND LOW CALIBRATIONS AND REPLACED THE NO CELL AS A PRECAUTIONARY MEASURE. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THE ROOT CAUSE FOR THIS INCIDENT WAS NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. CASE COMMENT: (B)(4)2014: THE DEVICE WAS NOT IN USE AT THE TIME OF DEVICE ISSUE AND 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 NUMBER 3004531588-2013-00022).