BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 3253098 · Received July 29, 2013

    Report

    Report Number
    0001831750-2013-06762
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED FUNCTIONS WERE NOT AVAILABLE FROM EITHER SIDERAIL DUE TO MALFUNCTIONING SIDERAIL CABLES. 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 BED FUNCTIONS WERE NOT AVAILABLE FROM EITHER SIDERAIL DUE TO MALFUNCTIONING SIDERAIL CABLES. 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
    353104 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1