BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BARIATRIC BED

    MDR report key: 3932261 · Received April 4, 2014

    Report

    Report Number
    1824206-2014-01095
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 9, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN COULD NOT REPRODUCE THE FAILURE. THE SIDERAILS WERE FUNCTIONING AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN ATTEMPTED TO TIGHTEN SCREWS ON THE FRAME THAT MOUNTS THE SIDERAIL TO BED. HE ALSO PUT WEIGHT ON SIDERAIL TO TEST IF IT WOULD COLLAPSE. THE BED SIDERAILS FUNCTIONED AS DESIGNED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT THE SIDERAIL FAILED WHILE TRYING TO MOVE PATIENT UP IN BED (SIDERAILS NOT LATCHING). THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205334 TOTAL CARE BARIATRIC BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1