BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADEL OBS 6/04

    MDR report key: 2022169 · Received March 10, 2011

    Report

    Report Number
    1831750-2011-02351
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT WON'T LOWER ALL THE WAY DOWN AND IT HAS NO TREND LIMIT. IT IS UNK IF THERE WAS PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEL OBS 6/04 LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK