BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 3810227 · Received February 5, 2014

    Report

    Report Number
    1824206-2014-00317
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THAT SOMEONE LEANED ON THE LEFT SIDE RAIL AND PULLED THE TOP ASSEMBLY LOOSE FROM THE SIDE RAIL FRAME. THE DEVICE REFERENCED IN THIS REPORT IS OVER 12 MONTHS OLD AND ACCORDING TO THE RECOMMENDED PREVENTIVE MAINTENANCE SCHEDULE AT LEAST ONE PM SHOULD BE PERFORMED EVERY 12 MONTHS. THEREFORE, THE ACCEPTANCE CRITERIA, BASED ON THE DHR WERE DETERMINED TO BE ACCEPTABLE AT THE TIME THE DEVICE WAS RELEASED. GIVEN THE TIME WHICH HAS ELAPSED, THE ALLEGED FAILURE OF THE DEVICE WOULD NOT BE RELATED TO ANY ISSUE WHICH OCCURRED DURING THE MANUFACTURING PROCESS. HILL-ROM TECH SUPPORT HAD MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER REGARDING A RESOLUTION FOR THIS ISSUE WITH NO RESPONSE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE UPPER PORTION OF THE SIDE RAIL HAD DETACHED FROM THE UPPER SIDE RAIL BRACKET. THE ACCOUNT STATED THE BED IS IN THEIR BED SHOP. THERE WAS NO PATIENT/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
    75767 TOTALCARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1