BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 1833964 · Received September 9, 2010

    Report

    Report Number
    1831750-2010-02200
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MATTRESS. CONCLUSIONS: REPLACEMENT OF THE MATTRESS HAS BEEN AUTHORIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOT END SECTION OF THE MATTRESS WAS BREAKING DOWN. NO ADVERSE CONSEQUENCES 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