BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 1920731 · Received December 6, 2010

    Report

    Report Number
    1831750-2010-04555
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE L/H LEG SUPPORT WILL NOT LOCK INTO ABDUCTION POSITION. THREE BOLTS SECURING FOOT REST PIVOT FELL OUT CAUSING LEG SUPPORT TO DROP DOWN. 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 LD304 MATERNITY BED LABOR AND DELIVERY BED HDD STRYKER CORP., MEDICAL DIV. 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK