BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    'STANDARDD STRETCHER'

    MDR report key: 3924707 · Received June 25, 2014

    Report

    Report Number
    3006697241-2014-00528
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE RIGHT SIDERAIL NOT LATCHING DUE TO A BENT RAIL RELEASE LATCH HANDLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2008 AND 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE RIGHT SIDERAIL LATCH TO RESOLVE THE ISSUE. 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 LEFT SIDERAIL IS 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 #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369587 'STANDARDD STRETCHER' WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

    Patients

    Seq Age Sex Outcome Treatment
    1