BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES ADULT BREATHING CIRCUIT

    MDR report key: 562573 · Received December 10, 2004

    Report

    Report Number
    MW1033978
    Event Type
    Malfunction
    Date Received
    December 10, 2004
    Report Date
    December 10, 2004
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FDA CLASS I RECALL ISSUED BY BIO-MED DEVICES, INC. LETTER STATED TO DISCONTINUE THE AFFECTED LOTS AND RETURN. THE PRODUCT WOULD BE INSPECTED AND RETURNED BY THE MFR. RPTR RECEIVED A CALL FROM BIO-MED DEVICES STATING THAT RPTR AS THE CUSTOMER COULD RE-INSPECT THE AFFECTED PART AND USE THE DEVICE WITHOUT SENDING BACK THE PRODUCT. THIS INFO WAS VERBAL AND NOT IN WRITTEN LETTER. RPTR EXPRESSED THEIR CONCERN OF THE CUSTOMER RE-INSPECTING THE AFFECTED PART AND NOT THE MFR AS THE FDA RECALL STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MED DEVICES ADULT BREATHING CIRCUIT VENTILATOR BREATHING CIRCUIT CAI BIO-MED DEVICES, INC. 80011 01102804

    Patients

    Seq Age Sex Outcome Treatment
    1 * PNEUMOTACH MODEL#4408, INCLUDED IN RECALL.