BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2564827 · Received April 25, 2012

    Report

    Report Number
    9616066-2012-00307
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    January 1, 2012
    Report Date
    April 6, 2012
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE BOTTOM OF THE DIAL-A-FLOW. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. 43000E 1111148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK