BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASIC CLICK STYLE REGULATOR

    MDR report key: 4643650 · Received March 25, 2015

    Report

    Report Number
    1062191-2015-00001
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    February 16, 2015
    Report Date
    March 24, 2015
    Manufacturer
    INOVO, INC.
    Product Code
    CAN
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), SPOKE WITH (B)(6). HE TOLD ME THAT A (B)(6) MALE PATIENT WAS POST OPERATIVE, AND PHYSICIAN THOUGHT HE SET OXYGEN FLOW ON THE 48155 MODEL REGULATOR TO 8LPM. AT SOME POINT LATER, THEY HAD DETERMINED THAT THE PATIENT WAS NOT GETTING ENOUGH OXYGEN FLOW AND THAT THE FLOW METER WAS SET BETWEEN 2 SETTINGS. I'D ASKED HIM FOR THE SERIAL #, BUT SAID THAT THE UNIT HAD BEEN PUT BACK INTO CIRCULATION. HE SAID THAT HE CHECKED OTHER UNITS OF THE SAME MODEL AND COULD DUPLICATE THE "NO FLOW BETWEEN SETTINGS" BEHAVIOR. I INFORMED (B)(6) THAT THIS WAS NOT A PRODUCT FAILURE, BUT THAT THIS IS THE WAY ALL CLICK STYLE REGULATORS OPERATE; OURS AND EVERY OTHER COMPANY THAT WE ARE FAMILIAR WITH, AND THIS IS NOT A PRODUCT FAILURE, BUT RATHER A METHOD OF OPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, RECEIVED CALL FROM (B)(6). HE STATED THAT A PATIENT WAS USING PART NO OM-4815-L-BLUE AND THE DIAL WAS DIALED IN BETWEEN THE NUMBERS. PER (B)(6), THE PATIENT WAS NOT RECEIVING OXYGEN WHILE THE UNIT WAS BETWEEN SELECTOR FLOW SETTINGS. AS A RESULT HE HAD AN ANOXIC BRAIN INJURY. THIS RESULTED IN A CARDIAC ARREST AND THE PATIENT WAS SENT TO THE HOSPITAL. HE WAS ON LIFE SUPPORT BUT HE HAS SINCE BEEN DISCHARGED. ON (B)(6) 2015, RECEIVED ANOTHER CALL FROM (B)(6) AND HE EXPLAINED THAT WHAT HAPPENED WAS THAT THE PATIENT WAS ALREADY IN THE HOSPITAL AND JUST HAD SURGERY. IT WAS THE OPERATING ROOM THAT WAS USING THE REGULATOR WHICH WAS BETWEEN FLOW SETTINGS WHEN THE SITUATION HAPPENED. PER (B)(6), THE NURSE DID NOT SEQUESTER THE UNIT SO THEY HAVE NO WAY OF KNOWING WHICH UNIT IT WAS. (B)(6) ALSO SAID THAT THEY BEGAN CODING (CPR) THE PATIENT ON (B)(6) 2015. THIS HAPPENED AROUND 23:48PM ON THE (B)(6) BECAUSE THE PATIENT ARRESTED IN ENROUTE TO THE RECOVERY ROOM. (B)(4)ALSO ADVISED THAT THE ANESTHESIOLOGIST SET THE REGULATOR BUT IT WAS BETWEEN 2 FLOWS AND THEY DID NOT KNOW. PER (B)(6), THE ORIGINAL SETTING WAS 8LPM. (B)(6) MENTIONED THAT THE PATIENT WAS TAKEN OFF THE ANESTHESIA MACHINE AND PLACED ON A PORTABLE TANK WITH A REGULATOR. THIS WAS DONE IN THE OPERATING ROOM BEFORE TRANSPORT TO THE RECOVERY ROOM. FINALLY THEY RECOGNIZED WHEN THEY GOT TO THE RECOVERY ROOM THAT HIS BREATHING HAD STOPPED AND FURTHER CHECKING THE HEART WAS NOT PUMPING AND THEY STARTED CPR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199908 BASIC CLICK STYLE REGULATOR OXYGEN REGULATOR CAN INOVO, INC. OM4815-L-BLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention