BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 1925622 · Received November 23, 2010

    Report

    Report Number
    1831750-2010-04142
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FNL
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALF SUPPORTS HAVE BEEN REQUESTED BACK FROM THE FIELD TO DETERMINE THE ROOT CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MATERNITY BED CALF SUPPORT IS LOOSE. THE SUPPORTS GETS LOOSE OVER TIME AND THERE IS NO ADJUSTMENT TO TAKE THE SLACK OUT OF THE OPERATING PARTS AS WEAR PROGRESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD304 MATERNITY BED LABOR AND DELIVERY BED FNL STRYKER CORP., MEDICAL DIVISION 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1