BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BED

    MDR report key: 4232639 · Received September 11, 2014

    Report

    Report Number
    1824206-2014-02242
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICIAN SUPPORT ADVISED THE ACCOUNT TO CHECK THE HEAD UP BUTTONS MAY BE STUCK ON THE SIDERAIL. THE ACCOUNT REPLACED THE SIDERAIL TO RESOLVE THE ISSUED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE HEAD SECTION CAME UP ON ITS OWN (SELF-RUN). 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 #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562911 AFFINITY 4 BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1