BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    597 SPACE SAVER

    MDR report key: 250016 · Received November 12, 1999

    Report

    Report Number
    2016493-1999-00226
    Event Type
    Malfunction
    Date Received
    November 12, 1999
    Product Code
    FRN
    Removal / Correction Number
    Z-300-8
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING THE SET WAS MISLOADED INTO THE PUMP, RESULTING IN A FREEFLOW CONDITION. THE PUMP WAS NOT IN USE ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 597 SPACE SAVER FRN 597 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA