BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 2935443 · Received January 3, 2013

    Report

    Report Number
    1831750-2013-90013
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CALF SUPPORT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CALF SUPPORTS WERE NOT LOCKING. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PT INVOLVEMENT OF IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3829 LD304 MATERNITY BED LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1