BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PC% PACKAGE B

    MDR report key: 6023327 · Received October 12, 2016

    Report

    Report Number
    2020813-2016-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830022469
    PMA / PMN Number
    K970163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO THE MANUFACTURER BY THEIR DISTRIBUTOR, PATTERSON COMPANIES' FIELD TECHNICIAN. THE INCIDENT OCCURRED IN THE DENTAL OPERATORY ROOM WHILE THE O2 REGULATOR EQUIPMENT WAS IN USE ON A PATIENT. THE DENTIST REPORTED THAT HE WAS WORKING WITH A PATIENT WHEN HE REACHED TO INCREASE THE OXYGEN WHEN THE REGULATOR EXPLODED, INJURING HIS HAND. THE UNIT SMOKED FOR A PERIOD OF TIME AND EVERYONE IN THE OFFICE EXITED THE AREA. THERE WAS NO HARM TO THE PATIENT OR ANY OTHER WORKER IN THE OFFICE. NO ADDITIONAL MEDICAL TREATMENT WAS SOUGHT BY THE DENTIST. HE REPORTED SELF-TREATMENT OF THE AFFECTED HAND. THERE WAS NO OTHER EQUIPMENT INVOLVED IN THE INCIDENT. IT HAS BEEN REPORTED THAT THIS UNIT IS AN OLDER MODEL (MANUFACTURED IN 1998) AND OUT OF WARRANTY. THERE ARE NO SERVICE RECORDS ON THE AFFECTED UNIT GOING BACK 4+ YEARS ACCORDING TO THE MANUFACTURER AND THE DISTRIBUTOR'S RECORDS. IT WAS ALSO REPORTED BY A SERVICE TECHNICIAN WHO EXAMINED THE AFFECTED UNIT AFTER THE INCIDENT THAT THERE WAS EVIDENCE THAT THE MANIFOLD HAD PREVIOUSLY BEEN TAMPERED WITH. A FULL INVESTIGATION OF THE RETURNED UNIT IS CURRENTLY UNDERWAY. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED IN THE ACCUTRON/CROSSTEX COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    AN ANESTHESIA GAS-MACHINE FLOWMETER AND 4 CYLINDER PORTABLE SYSTEM WERE IN USE DURING A DENTAL PROCEDURE. THE DENTIST OPERATING THE MACHINE EXPERIENCED INJURIES TO THE HAND WHEN THE O2 REGULATOR PORTION OF THE 4 CYLINDER PORTABLE SYSTEM EXPLODED. NO OTHER PATIENTS OR STAFF MEMBERS WERE AFFECTED BY THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675667 ULTRA PC% PACKAGE B GAS MACHINE FOR ANESTHESIA BSZ ACCUTRON, INC. 31975 NA 00813830022469

    Patients

    Seq Age Sex Outcome Treatment
    1