BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2

    MDR report key: 3883817 · Received February 13, 2014

    Report

    Report Number
    3006697241-2014-00143
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 16, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH INSPECTED THE BED AND FOUND THAT THE LATCH HOLE FOR THE LEFT FOOT SIDERAIL WAS NOT CENTERED IN THE MOUNTING BRACKET. THEREFORE, THE LATCH PIN WAS HITTING THE SIDE OF THE LATCH HOLE AND NOT GOING ALL THE WAY IN. PARTS HAVE BEEN ORDERED FOR THIS REPAIR. THE REPAIR WILL BE COMPLETED ONCE THE PARTS ARRIVE. A SEARCH FOR THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. IT IS UNK IF THE FACILITY PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE USER FACILITY MAINTENANCE DEPT STATING, A CHILD PT WAS IN BED PULLING ON THE LEFT FOOT END SIDERAIL WHEN THE SIDERAIL LATCH RELEASED AND THE CHILD FELL OUT OF THE BED AND HIT HIS HEAD ON THE FLOOR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYS AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96691 ADVANTA 2 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV P1190A000091

    Patients

    Seq Age Sex Outcome Treatment
    1