BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 3812542 · Received April 17, 2014

    Report

    Report Number
    1824206-2014-01247
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LEFT FOOT BRAKE CASTER WAS NOT HOLDING IN BRAKE. THE MOST LIKELY CAUSE IS DUE TO AGE AND NORMAL WEAR AND TEAR. THE TECHNICIAN SWAPPED THE RENTAL BED FOR A KNOWN WORKING BED. THE TECHNICIAN REPLACED THE LEFT FOOT BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE FACILITY. THERE WAS NO PATIENT/INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235914 TOTALCARE BARIATRIC PLUS BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1