BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 3201960 · Received July 2, 2013

    Report

    Report Number
    0001831750-2013-05960
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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

    IT WAS INITIALLY REPORTED THAT THE FOOT SECTION HAD A BROKEN WELD WHICH MAY HAVE CAUSED THE CALF SUPPORT NOT TO LOCK INTO POSITION. FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE BROKEN FOOT SECTION WELD IS AN ANNOYANCE ISSUE ONLY. IT WAS CONFIRMED NO BED FUNCTIONS WERE AFFECTED AND NO SHARP EDGES WERE REPORTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    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 VIA REPAIR WORK ORDER THAT THE FOOT SECTION HAD A BROKEN WELD WHICH MAY HAVE CAUSED THE CALF SUPPORT NOT TO LOCK INTO POSITION. 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 VIA REPAIR WORK ORDER THAT THE FOOT SECTION HAD A BROKEN WELD WHICH MAY HAVE CAUSED THE CALF SUPPORT NOT TO LOCK INTO POSITION. 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
    302408 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1