BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX / POM

    MDR report key: 7781001 · Received August 14, 2018

    Report

    Report Number
    3010411911-2018-00001
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    May 9, 2018
    Report Date
    August 13, 2018
    Manufacturer
    POM MEDICAL, LLC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER RECEIVED THE MEDWATCH REPORT (UF / IMPORTER REPORT #) (B)(4), ON JUNE 11, 2018. AFTER RECEIPT OF THE REPORT, THE DEVICE MANUFACTURER COMPLETED AN INVESTIGATION OF THE DEVICE RETURNED BY THE USER FACILITY FOR EVALUATION. AS PART OF THIS EVALUATION, A SUPPLIER CORRECTIVE ACTION WAS SUBMITTED TO POM MEDICAL'S CONTRACT MANUFACTURER TO COMPLETE AN INVESTIGATION ON THE NOTED PRODUCT PROBLEM. THE COMPLETED INVESTIGATION DETERMINED THAT THE PRODUCT PROBLEM WAS ONLY PRESENT IN THE HIGH CONCENTRATION ADAPTER RE-BREATHER BAG COMPONENT, SUPPLIED BY ANOTHER MANUFACTURER. EVEN THOUGH THERE WAS NO PATIENT DEATH OR SERIOUS INJURY AND THE IFU INSTRUCTS CLINICIANS TO TEST AIRFLOW FROM THE RE-BREATHER BAG PRIOR TO USING THE PRODUCT, THE MANUFACTURER IS RESPONDING TO THE FILED MEDWATCH IN AN ABUNDANCE OF CAUTION AND TO SUPPLEMENT ITS VOLUNTARY REMEDIAL ACTION.

    Description of Event or Problem · 1

    AS OUTLINED IN MEDWATCH (UF / IMPORTER REPORT #) (B)(4), THE INITIAL REPORTER INDICATED THAT THE "CLINICIAN COULD NOT GET OXYGEN READING ON PATIENT, AS THERE WAS NO HOLD IN O2 CONNECTION ON MASK." HOWEVER, UPON FURTHER INVESTIGATION BY THE MANUFACTURER WITH THE COMPLAINANT TO CLARIFY THE INCIDENT, IT WAS DETERMINED THAT THE CLINICIAN COULD NOT GET OXYGEN TO FILL THE REBREATHER BAG AND THE AIRFLOW WAS NOT TESTED PRIOR TO PROCEDURE DESPITE THE INSTRUCTION IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620907 CURAPLEX / POM POM 1001-MM BYG POM MEDICAL, LLC. POM 1001-MM 022218-022221

    Patients

    Seq Age Sex Outcome Treatment
    1