BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE MODEL 4P PUMP NO I/O

    MDR report key: 336522 · Received June 1, 2001

    Report

    Report Number
    2921482-2001-00206
    Event Type
    Malfunction
    Date Received
    June 1, 2001
    Date of Event
    March 16, 2001
    Report Date
    April 30, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF THE DEVICE FAILING DELIVERY ACCURACY IN PREVENTATIVE MAINTENANCE TESTING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN PATIENT USE. THE CUSTOMER COULD NOT RECALL IF THE DEVICE OVER OR UNDER-DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25694 LIFECARE MODEL 4P PUMP NO I/O INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other