BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW

    MDR report key: 1876303 · Received October 15, 2010

    Report

    Report Number
    MW5017771
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 14, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNABLE TO DETERMINE WHETHER ON-Q PUMP WAS WORKING; PATIENT HAD ALTERNATIVE METHOD OF PAIN RELIEF WITH A DILAUDID PCA PUMP. ON-Q PUMP APPEARED FULL WHEN IT WAS DISCONTINUED. UNABLE TO DETERMINE IF THE ON-Q PUMP WAS FUNCTIONING. PACKAGING WAS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON-Q PUMP MEB I-FLOW CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR