BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B&F MEDICAL PRODUCTS

    MDR report key: 218805 · Received April 13, 1999

    Report

    Report Number
    MW1016115
    Event Type
    Malfunction
    Date Received
    April 13, 1999
    Date of Event
    April 5, 1999
    Report Date
    April 13, 1999
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REGULATOR WAS SENT OUT FOR REPAIR AND WAS RETURNED "RED TAGGED", WITH SIGNS OF HEAT DAMAGE. THE DEVICE HAD SCORCHING AND METAL DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B&F MEDICAL PRODUCTS O2 REGULATOR CAW ALLIED HEALTHCARE PRODUCTS, INC. 81017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA