BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 3241152 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06553
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    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

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOTREST WAS NOT LOCKING IN PLACE PROPERLY DUE TO A WORN MECHANISM. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOTREST WAS NOT LOCKING IN PLACE PROPERLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340486 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1