BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2591530 · Received May 23, 2012

    Report

    Report Number
    9616066-2012-00353
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Report Date
    May 7, 2012
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE LEAK BECAUSE THE SET WAS NOT RETURNED. CUSTOMER STATES THAT PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED.

    Description of Event or Problem · 1

    RECEIVED REPORT STATING A SET WAS LEAKING AT THE FLOW REGULATOR. RN STATES THE SET WAS IN USE ON A PT AND WAS NOTED TO BE LEAKING ONTO THE BED. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. 43000E 1112078

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK