BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 4806239 · Received May 29, 2015

    Report

    Report Number
    0001831750-2015-00252
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 1, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ORDERED PARTS AND PERFORMED THEIR OWN REPAIRS. CUSTOMER PERFORMED OWN EVALUATION AND ORDERED PARTS FOR REPAIR.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K950889.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UPRIGHT ASSEMBLY WOULD NOT STAY UP AND DAMAGED OTHER COMPONENTS, REQUIRING THE ENTIRE CALF SUPPORT TO BE REPLACED . 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 THE UPRIGHT ASSEMBLY WOULD NOT STAY UP AND DAMAGED OTHER COMPONENTS, REQUIRING THE ENTIRE CALF SUPPORT TO BE REPLACED. 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
    350723 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1