BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 7076506 · Received December 1, 2017

    Report

    Report Number
    3004531588-2017-00093
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    UDI-DI
    00867538000106
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS (B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 15-NOV-2017. THE REGIONAL SERVICE LOG REVIEW INDICATES THE DEVICE WAS POWERED ON (B)(6) 2017 AND RAN FOR 5 DAYS BEFORE THE SYSTEM WAS POWERED OFF. THE LOG DOES NOT INCLUDE VERIFICATION OF AN ELECTRONIC SYSTEM SHUTDOWN OR OTHER ALARMS INDICATING A DEVICE FAULT. THE LOG DOES, HOWEVER INDICATE THE POWER STATUS SWITCHING BETWEEN AC POWER AND BATTERY POWER OVER THE 5 DAYS THE DEVICE WAS RUNNING, AND THE DEVICE WAS RUNNING ON AC PRIOR TO THE LAST EVENT. THIS INDICATES THAT THE DEVICE WAS MANUALLY SWITCHED OFF AND ON DURING THE DAY OF THE REPORTED EVENT. THE RSC SERVICE LOG INVESTIGATION WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT, AND NO DEVICE SHUTDOWN WAS EXPERIENCED OR RECORDED DURING THE TIME OF THIS ALLEGED ISSUE. THE ROOT CAUSE FOR THE OXYGEN DESATURATION IS NOT ABLE TO BE DETERMINED. THE ROOT CAUSE FOR THE REPORTED UNEXPECTED SYSTEM SHUTDOWN IS USER ERROR AS THE REPORTER STATED THAT THE DEVICE MAY HAVE BEEN INADVERTENTLY POWERED TO STANDBY. ADDITIONALLY THERE IS NO EVIDENCE IN THE LOG OF ANY ALARMS OR CONDITIONS THAT WOULD HAVE CAUSED THE SCREEN TO GO "DARK." THE LOG DOES SHOW HOWEVER, EVIDENCE THAT THE INOMAX DSIR PLUS WAS MANUALLY POWERED TO STANDBY AND THEN BACK ON THE SAME DAY THAT THE REPORTED EVENT OCCURED. MALLINCKRODT PRODUCT SUPPORT FOLLOWED UP WITH THE CUSTOMER VIA A PHONE CALL AND OFFICIAL LETTER TO EXPLAIN THE POSSIBLE USER ERROR. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A RESPIRATORY THERAPIST (RT) FROM THE UNITED STATES CALLED MALLINCKRODT CUSTOMER CARE TO REPORT A DEVICE ISSUE WITH INOMAX DSIR PLUS (B)(4). THE REPORTER STATED THAT THE PATIENT EXPERIENCED AN OXYGEN DESATURATION ON (B)(6) 2017. IT WAS STATED THAT THE PATIENT WAS TRANSPORTED TO THE CARDIAC CATHETERIZATION LAB ON INOMAX AT 20 PPM. AT THE TIME OF THE INCIDENT THE PATIENT WAS IN THE CARDIAC CATHETERIZATION LAB. THE REPORTER STATED THAT SHORTLY AFTER ANESTHETIC INDUCTION, THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) NOTED THE PATIENT'S OXYGEN SATURATION DECREASED INTO THE 80'S FROM A BASELINE OF 93%. FIO2 (FRACTION OF INSPIRED OXYGEN) WAS INCREASED AND THE ANESTHESIOLOGIST WAS CALLED BACK INTO THE ROOM. THE PHYSICIAN RECALLED THAT PRIOR TO HIM LEAVING THE ROOM AFTER THE PATIENT WAS INDUCED, HE HAD ASKED SOMEONE TO ROTATE/MOVE THE DSIR PLUS SO HE WAS BETTER ABLE TO SEE THE SCREEN. HE REPORTED THAT THE DSIR PLUS MAY HAVE INADVERTENTLY BEEN POWERED TO STANDBY AT THAT TIME. DURING PATIENT ASSESSMENT, BILATERAL BREATH SOUNDS AND DECREASED CHEST EXCURSION WAS NOTED. THE PATIENT WAS SUCTIONED AND ALBUTEROL WAS ADMINISTERED. IT WAS REPORTED THAT THE PATIENT BRIEFLY CONTINUED OXYGEN DESATURATION, DECREASING FOR 5 TO 6 MINUTES TO 50% - 70% RANGE WITH PATIENT ON 100% FIO2. THE EQUIPMENT WAS CHECKED AND THE ANESTHESIOLOGIST NOTED THAT THE DSIR PLUS APPEARED TO BE OFF (DARK SCREEN). IT WAS STATED THAT NO ALARMS HAD BEEN REPORTED PRIOR TO THIS. THE PHYSICIAN TURNED THE DEVICE BACK ON BUT WAS HAVING DIFFICULTY PERFORMING THE PRE-USE CHECK SINCE THE PHYSICIAN WAS UNFAMILIAR WITH THE PROCEDURE. THE PATIENT WAS HAND VENTILATED WITH 100% OXYGEN AND 20 PPM UTILIZING THE INOBLENDER UNTIL RESPIRATORY PERSONNEL ARRIVED WITH A REPLACEMENT DSIR PLUS. THE PATIENT WAS STABILIZED AND PLACED ONTO THE SECOND DEVICE AND THE CARDIAC CATHETERIZATION WAS COMPLETED WITHOUT FURTHER ISSUE. INOMAX DSIR PLUS (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854136 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L| O