BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIB-MESH NEBULIZER

    MDR report key: 1765145 · Received July 15, 2010

    Report

    Report Number
    9616390-2010-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    February 24, 2010
    Report Date
    July 14, 2010
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Product Code
    CAF
    PMA / PMN Number
    K081738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERTAIN PRECAUTIONARY AND WARNING STATEMENTS HAVE BEEN COPIED FROM THE USER'S MANUAL. THESE ARE CONSOLIDATED ON A PACKAGE INSERT AND INSERTED IN THE DEVICE PACKAGING TO HEIGHTEN THE USER'S AWARENESS TO POTENTIAL DAMAGE OF THE MESH RESULTING FROM IMPROPER CLEANING PROCEDURES. PACKAGE INSERTS AND INSTRUCTIONS FOR THEIR USE WILL BE PROVIDED TO ALL DISTRIBUTORS WORLDWIDE FOR THE UPDATE OF EXISTING PRODUCT IN STOCK. ALL DEVICE EVALUATION INFORMATION IS BEING TRANSLATED FROM (B)(6) TO ENGLISH FOR YOUR REVIEW. THE TRANSLATED DEVICE EVALUATION INFORMATION WILL BE INCLUDED IN A FOLLOW-UP FORM FDA 3500A, WHICH WILL BE SUBMITTED BY JULY 29, 2010. ADDITIONAL DEVICE MANUFACTURE DATE: 09/2009.

    Description of Event or Problem · 1

    NO PATIENT/USER INFORMATION PROVIDED BY THE DISTRIBUTOR. HEALTH AND LIFE CO, LTD RECEIVED A PRODUCT RETURN OF ONE UNIT OF THE MODEL HL100 VIB-MESH NEBULIZER ASSOCIATED WITH THE COMPLAINT NUMBER (B)(4). THE COMPLAINT INDICATED THAT THE PRODUCT BEGAN TO LEAK AFTER A BRIEF PERIOD OF USE. EVALUATION OF THE PRODUCT REVEALED THAT THE MESH WAS RUPTURED, WHICH PREVENTS THE PRODUCT FROM OPERATING PROPERLY. VISUAL INSPECTION OF THE MESH REVEALED AN INDENTATION IN THE MESH THAT COULD ONLY BE CAUSED BY CONTACTING THE MESH WITH A FOREIGN OBJECT OF SOME SORT. THIS NEBULIZER CAN BE USED TO DELIVER A VARIETY OF MEDICATIONS, INCLUDING MEDICATIONS FOR THE TREATMENT OF ACTIVE ASTHMA ATTACKS, ESPECIALLY IN PEDIATRIC PATIENTS, SINCE THEY HAVE DIFFICULTY USING A TYPICAL "RESCUE INHALER." A FAILURE OF THE DEVICE TO FUNCTION PROPERLY DURING SUCH A USE COULD CONTRIBUTE TO SERIOUS INJURY OR DEATH. WHILE THERE IS A SAFETY PRECAUTION IN THE INSTRUCTION MANUAL WARNING AGAINST CONTACTING THE MESH WITH A Q-TIP OR OTHER FOREIGN OBJECT CONTAINED ON PAGE 3 OF THE INSTRUCTION MANUAL, IT IS LISTED AMONG A VARIETY OF CAUTION STATEMENTS. AS SUCH, THERE MAY BE CIRCUMSTANCES WHERE THE USER DOES NOT READ THIS PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIB-MESH NEBULIZER NEBULIZER CAF HEALTH & LIFE CO., LTD. HL100 SEE H.10 OF FORM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA