BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 3881913 · Received June 18, 2014

    Report

    Report Number
    0001831750-2014-03092
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    HDD
    PMA / PMN Number
    K950889 
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO REPORT THAT DURING CONVERSATION WITH THE USER FACILITY, IT WAS REPORTED THAT "DURING A LABOR DELIVERY, A DOCTOR NEEDED TO REMOVE THE SLIDE OFF FOOT SECTION OF THE BED. HE WAS STRUGGLING TO GET THE SLIDE SECTION OFF, AND WITH THE BABY COMING, HE DECIDED TO FORCEFULLY SIT ON THE EDGE OF THE FOOT SECTION TO GET IT TO RELEASE. THIS CAUSED THE FOOT SECTION TO BREAK AT THE SLIDE-IN POINT OF THE FOOT SECTION AND THE FOOT SECTION DISLODGED FROM ITS POSITION AND BOTH THE DOCTOR AND THE FOOT SECTION FELL TO THE FLOOR.¿

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE DOCTOR DOING THE DELIVERY SAT ON THE EDGE OF THE SLIDE-OFF FOOT SECTION, AND THAT BOTH FELL TO THE FLOOR. THE FOOT SECTION WAS FOUND TO BE BENT. NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE DOCTOR DOING THE DELIVERY SAT ON THE EDGE OF THE SLIDE-OFF FOOT SECTION, AND THAT BOTH FELL TO THE FLOOR. THE FOOT SECTION WAS FOUND TO BE BENT. NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356947 LD304 MATERNITY BED TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)  HDD STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1