INOMAX DSIR (DELIVERY SYSTEM)

Description of Event or Problem

FAILURE OF FUEL CELL (DEVICE MALFUNCTION). CASE DESCRIPTION: ON (B)(6) 2014 A MEDSUN SAFETY REPORT, USER FACILITY # (B)(4) WAS RECEIVED BY IKARIA FROM THE FDA. THE REPORT STATES THAT ON (B)(6) 2014 "THE INOVENT (SERIAL (B)(4) ) SET AT 40 PARTS PER MILLION (PPM) BEGAN TO ALARM DUE TO ONLY READING 20 PPM. AFTER RECALIBRATION OF THE DEVICE, IT FAILED DUE TO FAILURE OF FUEL CELL. THE INOVENT WAS SWITCHED OUT WITH NO ISSUES. THE PATIENT TOLERATED ALL OF THIS WITHOUT ANY SIGNS OF DISTRESS. " IT IS IMPORTANT TO NOTE THAT IN THE UNITED STATES IKARIA REPLACED ALL COMMERCIALLY USED INOVENT DEVICES WITH THE INOMAX DSIR BY (B)(4) 2013, THEREFORE ALTHOUGH THE THEREFORE ALTHOUGH THE REPORTER LISTED THE DEVICE BRAND/TYPE AS INOVENT IT WAS THE INOMAX DSIR THAT WAS IN USE AT THE TIME OF THE DEVICE ISSUE. A SEARCH OF THE IKARIA SAFETY DATABASE REVEALED NO SAFETY REPORTS FOR THE INOMAX DSIR (SERIAL # (B)(4) ) DURING THE TIMEFRAME INDICATED ON THE MEDSUN REPORT. A SEARCH OF THE IKARIA COMPLAINT DATABASE REVEALED A COMPLAINT RECEIVED ON (B)(6) 2014 FROM A HOSPITAL IN THE UNITED STATES REPORTING A FAILED OXYGEN SENSOR ON THE INOMAX DSIR (B)(4). LOW AND HIGH CALIBRATIONS WERE PERFORMED BY THE RT WITHOUT RESOLUTION OF THE DEVICE ALARM. THE RT DID NOT MENTION THAT THE DEVICE WAS ON A PATIENT. THE DEVICE WAS RETURNED TO IKARIA FOR INSPECTION.

Additional Manufacturer Narrative

INVESTIGATION RESULTS COMPLETED ON (B)(4) 2014. AS IS IKARIA'S PRACTICE, THIS MANUFACTURER,S MDR IS BEING SUBMITTED IN RESPONSE TO THE RECEIPT OF A USER MDR FROM THE FDA. A MEDWATCH FORM WAS NOT SUBMITTED AT THE TIME THE EVENT WAS ORIGINALLY REPORTED TO IKARIA BY THE HOSPITAL BECAUSE THE DEVICE ISSUE WAS NOT ASSOCIATED WITH AN ADVERSE EVENT TO A PATIENT. INOMAX DSIR DEVICE SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOGS WHICH DID NOT CONFIRM THE REPORTED COMPLAINT OF FAILED OXYGEN (O2) SENSOR ALARMS BUT DID REVEAL FAILED NITRIC OXIDE (NO) SENSOR ALARMS. THE INITIAL NO SENSOR ALARM OCCURRED WITH CONCENTRATION COUNTS (56) LESS THAN THE MINIMUM REQUIRED 57 COUNTS CONSISTENT WITH NO CELL SATURATION. RSC INVESTIGATION COULD NOT CONFIRM THE O2 CELL FAILURE BUT REPLACED THE O2 CELL AS A PRECAUTION AND THE NO CELL DUE TO LOG ENTRIES. THE ROOT CAUSE FOR THIS INCIDENT WAS NO CELL SATURATION.