BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SUPPORT FLOW METER

    MDR report key: 271598 · Received March 21, 2000

    Report

    Report Number
    MW1018527
    Event Type
    Malfunction
    Date Received
    March 21, 2000
    Date of Event
    September 1, 1999
    Report Date
    March 20, 2000
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DUE TO RECALL AND PREVIOUS ALERT ON THE LSP 270-220 REGULATORS, USER FIRST UPDATED THE REGULATORS WITH NEW FILTERS AND WHEN RECALL WAS PUT INTO EFFECT, USER ORDERED 10 NEW LSP REGULATORS, THREE CAME IN AND WERE PUT INTO SVC APPROX 6 WEEKS AGO. APPROX 8 TO 10 DAYS AGO WHEN USER WENT TO REFILL THE 0/2 TANK THEY NOTICED THE TWO PINS THAT ARE USED AS TO LINE UP THE FLOW METER WITH THE O/2 TANK WERE MISSING FROM THIS REGULATOR. USER HAD USED THIS REGULATOR ON CALLS SINCE THE DAY THEY WERE PUT INTO SVC AND THE PINS WERE IN THE UNIT. THIS WAS VERIFIED BY THE CREW. USER CALLED ALLIED HEALTH CARE AND THEY WANTED USER TO MAIL THEM THE REGULATOR. USER HAS NOT DONE THIS DUE TO THE FACT THAT, APPROX 6 YEARS AGO USER MAILED THEM A FAULTY NEW O/2 REGULATOR THAT ONE OF FIRST RESPONDER UNITS HAD JUST ORDERED. AFTER AN EXTENDED PERIOD OF TIME USER WROTE AND CALLED THEM AND WERE TOLD THEY WOULD NOT REPAIR, REPLACE, OR SHIP THE REGULATOR BACK. THIS MAKES USER RELUCTANT TO SHIP THEM ANOTHER REGULATOR. USER DEEMED TO MISSING ALIGNMENT PINS AS A POSSIBLE DANGEROUS SITUATION, AS WITHOUT PROPER ALIGNMENT ONE COULD HAVE O/2 ESCAPING FROM THE TANK UNDER HIGH PRESSURE WITH THE POSSIBILITY OF FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE SUPPORT FLOW METER O2 REGULATOR CAN ALLIED HEALTH CARE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *