BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLIED DISPOSABLE COLLECTION UNIT

    MDR report key: 2354846 · Received November 8, 2011

    Report

    Report Number
    1924066-2011-00008
    Event Type
    Other
    Date Received
    November 8, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 8, 2011
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    JCX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DESCRIPTION OF THE PRODUCT THE PRODUCT IS OVER 2 YRS OLD. BRITTLENESS IS CAUSED BY EXPOSURE TO ELEVATED TEMPERATURES AND UV LIGHT FOR EXTENDED PERIODS. SAMPLES HAVE NOT BEEN RETURNED FOR EVAL THEREFORE THE EXACT CAUSE CAN NOT BE DETERMINED. IF THE UNIT WAS INDEED STORED ON A CRASH CART, IT WAS EXPOSED TO UV (FLUORESCENT) LIGHT. THE STORAGE CONDITIONS ARE CLEARLY STATED IN THE PRODUCT INSERT. THIS IS A DISPOSABLE DEVICE AND IS EXPECTED TO BE USED WITHIN 12 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE SUCTION CANISTERS ARE DESIGNED TO WORK WITH A PORTABLE SUCTION UNIT KEPT ON THE CRASH CART. WHEN CHECKING THE CART EACH DAY THE SUCTION EQUIPMENT IS TESTED. ON SEVERAL OCCASIONS, THE LID OF THE SUCTION CANISTER CRACKED WHEN THE SUCTION WAS TESTED. THIS OCCURRED WITH MORE THAN ONE UNIT. THE LID OF ONE CANISTER IMPLODED INTO THE CANISTER WHEN SUCTION WAS TESTED. THE LIDS ARE EXCEPTIONALLY BRITTLE AND CRACK EASILY. IT WAS NOTED THAT A LID FROM A PRIOR SHIPMENT WAS MORE TRANSLUCENT IN COLOR AND APPEARED TO BE MORE FLEXIBLE. THERE WEREN'T ANY ISSUES WITH THAT LID. THE LIDS IN THE NEW CASE OF PRODUCT ALSO APPEAR TO BE MORE TRANSLUCENT AND FLEXIBLE. THE LIDS THAT WERE PROBLEMATIC ARE OPAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIED DISPOSABLE COLLECTION UNIT DISOPOSABLE COLLECTION UNIT JCX ALLIED HEALTHCARE PRODUCTS, INC. 20-08-0016

    Patients

    Seq Age Sex Outcome Treatment
    1