BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRON ULTRA PC % FLOWMETER

    MDR report key: 4146800 · Received September 23, 2014

    Report

    Report Number
    2020813-2014-00001
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K970163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THREE UNITS HAVE BEEN EVALUATED AND QUALIFIED AGAINST FACTORY SPECIFICATIONS. THE INSTRUCTIONS FOR USE AND PRODUCT LABELING WERE REVIEWED AND FOUND ACCEPTABLE. THE UNITS WERE DISTRIBUTED IN SEPTEMBER OF 2013 WITH NO PREVIOUSLY REPORTED ISSUES RECORDED. ALL (B)(4) UNITS HAVE BEEN RETURNED TO THE CUSTOMER FOR CONTINUED USE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE USER FACILITY REPORTED THAT VARIOUS PATIENTS WERE HAVING ADVERSE REACTIONS WHEN USING OUR ULTRA PC % FLOWMETERS. THEY INDICATED THAT THIS HAD STARTED UPON THE DELIVERY OF NEW N2O / O2 GAS CYLINDERS. THEY REPORTED THAT THE PRODUCTS IN QUESTION WERE THREE DIFFERENT FLOWMETERS PN: 31975 (SN: (B)(4)). THEY REPORTED AS HAVING ADVERSE REACTIONS WITH A FEW OF THEIR PATIENTS AND IN ONE CASE THEY NEEDED TO MAKE A "911" CALL. IT WAS INDICATED THAT THEY WERE FOLLOWING THE TITRATION METHOD DURING THE DENTAL PROCEDURES AND DISCONTINUED TREATMENT. NO OTHER DETAILS REGARDING THE 911 CALL, ADDITIONAL ACTIONS TAKEN, DETAILS ON THE PT INVOLVED, AND THE MEASURE OF ANY MEDICAL INTERVENTION WERE INITIALLY PROVIDED. ON (B)(6) 2014 THE USER FACILITY DID PROVIDE THE INFO INDICATING THAT A PEDIATRIC PT HAD STOPPED BREATHING AND WAS UNRESPONSIVE DURING THE DENTAL PROCEDURE AND THAT HIS PULSE RATE HAD LOWERED TO BETWEEN 60 - 65. IT WAS INDICATED THAT AFTER TREATING THE PT WITH O2 THAT THE PT RECOVERED AND WAS RESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591481 ACCUTRON ULTRA PC % FLOWMETER ANALOG FLOWMETER BSZ ACCUTRON, INC. 31975 110654

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention