BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULATOR

    MDR report key: 7061037 · Received November 27, 2017

    Report

    Report Number
    1062191-2017-00011
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 27, 2017
    Manufacturer
    INOVO, INC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT IS PART OF THE 3100-SERIES REGULATORS PRODUCT FAMILY. SINCE THE 3100-SERIES REGULATORS ARE MANUFACTURED IN SEVERAL POSSIBLE CONFIGURATIONS, THE MODEL NUMBER WAS REVIEWED IN DETAIL TO DETERMINE THE SPECIFIC CONFIGURATION AND DEVICE SPECIFICATIONS OF THE UNIT. THE UNIT'S MODEL NUMBER IS SE3125-L; A 3100-SERIES REGULATOR WITH FLOWS UP TO 25 LITERS PER MINUTE, STANDARD CANNULA HOSE BARB, LEFT HANDED PRESSURE GAGE, AND PRIVATELY MARKED FOR SOUTHEASTERN EMERGENCY EQUIPMENT. FOR MODEL NUMBER SE3125-L, THE BRASS CORE (PN: 310012) IS MANUFACTURED SYMMETRICALLY WITH TWO HIGH-PRESSURE PORTS TO ALLOW THE SAME CORE TO BE USED FOR BOTH THE LEFT-HANDED AND RIGHT-HANDED CONFIGURATIONS (DETERMINED BY THE PLACEMENT OF THE PRESSURE GAUGE). DURING DEVICE ASSEMBLY, A PRESSURE GAUGE (PN: 440016) IS INSERTED INTO ONE OF TWO HIGH PRESSURE PORTS. THE OPPOSITE PORT IS FITTED WITH A BRASS PLUG (PN: 166905) TO SEAL THE ORIFICE. BOTH HIGH-PRESSURE PORTS ARE UNREGULATED PRESSURE AND FLOW, AND INTENDED ONLY FOR THE PRESSURE GAUGE OR BRASS PLUG. THE 3100-SERIES REGULATORS HAVE ONLY ONE REGULATED, LOW-PRESSURE OUTLET. THIS OUTLET IS EQUIPPED WITH EITHER A STANDARD CANULA HOSE BARB (PN: 166970) OR DISS FITTING (PN: 480007). THERE ARE NO PRODUCT VARIATIONS OF THE 3100-SERIES REGULATOR PRODUCT FAMILY WHERE A DEVICE IS EQUIPPED WITH BOTH A CANNULA HOSE BARB AND A DISS FITTING. INOVO VISUALLY INSPECTED THE UNIT AND OBSERVED THAT THE UNIT WAS EQUIPPED WITH A DISS FITTING CONNECTED TO ONE OF THE HIGH-PRESSURE PORTS (INTENDED ONLY FOR A PRESSURE GAUGE OR BRASS PLUG) AND A STANDARD HOSE BARB CONNECTED TO THE LOW-PRESSURE PORT. BASED UPON THE REVIEW AND EVALUATION OF THE APPLICABLE 3100-SERIES REGULATOR MODEL NUMBER SPECIFICATIONS AND THE RETURNED UNIT, THE ADDITION OF A DISS FITTING CONNECTED TO ONE OF THE HIGH-PRESSURE PORTS IS EVIDENCE THE UNIT HAD BEEN TAMPERED WITH/ALTERED FROM THE ORIGINAL DESIGN AND PRODUCTION. WHILE THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY AND IT WAS CLEAR THROUGH INSPECTION OF THE RETURNED UNIT THAT THE DEVICE WAS MODIFIED AND TAMPERED WITH, INOVO IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    AS DESCRIBED IN AN EMAIL FROM (B)(6), AN AREA SUPERVISOR WITH EXCELSIOR AMBULANCE SERVICE, ON (B)(6) 2017, THE (B)(6) OFFICE HAD A CRITICAL FAILURE OF A PORTABLE OXYGEN REGULATOR WITH A PATIENT THAT WAS ON BIPAP. A 6" HOSE WITH QUICK DISCONNECT WAS USED TO TRANSFER THE OXYGEN SOURCE FROM THE WALL OUTLET TO THE PORTABLE OXYGEN TANK. THE SHORT HOSE WAS SCREWED ONTO THE DISS FITTING PRIOR TO THE USE OF THE QUICK DISCONNECT. AT APPROXIMATELY 2100 HOURS, THE CREW WAS READY TO MOVE THE PATIENT TO THE AMBULANCE AND THEY DISCONNECTED THE OXYGEN HOSE FROM THE WALL OUTLET AND QUICK CONNECTED TO THE PORTABLE. AT THAT TIME, THE DISS PORT EXPLODED THE SHORT HOSE OFF OF THE REGULATOR. THERE ARE BURN PATTERNS INSIDE BOTH THE OXYGEN HOSE AND THE DISS PORT. THOUGH THE PATIENT WAS NOT INJURED AS A RESULT OF THIS FAILURE, THE PARAMEDIC SUFFERED A VERY MINOR INJURY, BUT DID NOT SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838431 REGULATOR PORTABLE OXYGEN REGULATOR CAN INOVO, INC SE3125-L 9342

    Patients

    Seq Age Sex Outcome Treatment
    1