BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANIFOLD

    MDR report key: 28853 · Received November 22, 1995

    Report

    Report Number
    1914522-1995-00013
    Event Type
    Malfunction
    Date Received
    November 22, 1995
    Report Date
    November 20, 1995
    Manufacturer
    WESTERN ENTERPRISE MEDICAL LTD.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MANIFOLD PRESSURE WOULD DROP TO ZERO AFTER SWITCHING TO THE RESERVE SIDE WITH FULL CYLINDERS. THE CUSTOMER COULD NOT GET THE MANIFOLD TO WORK ON EITHER BANK. THE CUSTOMER SWITCHED TO A BACK-UP "E" CYLINDER WITHOUT INCIDENT. THE SVC TECH FOUND THE PROBLEM WAS CAUSED BY THE SOLENOIDS BECOMING MECHANICALLY LOCKED IN THE ENERGIZED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANIFOLD OXYGEN MANIFOLD BZO WESTERN ENTERPRISE MEDICAL LTD. HQ2

    Patients

    Seq Age Sex Outcome Treatment
    1 *