BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINTY THREE BIRTHING BED

    MDR report key: 3810362 · Received April 11, 2014

    Report

    Report Number
    1824206-2014-01147
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    PMA / PMN Number
    K915779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT DID NOT KNOW THE CAUSE OF THE SELF-RUN OF THE HEAD SECTION BUT TROUBLESHOT THE BED AND NARROWED IT DOWN TO THE RIGHT OUTSIDE CAREGIVER BOARD. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009 THROUGH 2010. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE ACCOUNT REPLACED THE RIGHT OUTSIDE CAREGIVER BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE HEAD UP HAS UNINTENTIONAL FUNCTION. THE BED WAS LOCATED IN THE REPAIR SHOP AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221529 AFFINTY THREE BIRTHING BED BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1