BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL STRETCHER

    MDR report key: 3843755 · Received February 12, 2014

    Report

    Report Number
    3006697241-2014-00140
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICIAN SUPPORT SPOKE WITH THE ACCOUNT AND GAVE THEM THE PART NUMBERS FOR THE SIDE RAIL LATCH AND HARDWARE THAT ARE NEEDED. NO INFO WAS GIVEN ON HOW THE PARTS BECAME MISSING. PER THE HILL-ROM SERVICE MANUAL IT IS NECESSARY FOR STRETCHERS TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTATIVE MAINTENANCE. MAKE SURE THE SIDE RAILS ARE NOT BENT OR TWISTED. MAKE SURE THE LATCH MECHANISMS OPERATE CORRECTLY. YOU MUST HEAR AN AUDIBLE CLICK WHEN THE SIDE RAIL IS RAISED TO THE UP POSITION. CHECK FOR LOOSE OR MISSING HARDWARE. TIGHTEN, REPAIR OR REPLACE AS NECESSARY. THE ACCOUNT WILL REPLACE THE LEFT SIDE RAIL LATCH, BUSHING, SCREW AND NUT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE LEFT SIDE RAIL LATCH WAS MISSING SO THE SIDE RAIL COULD NOT LATCH. THE STRETCHER IS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PT/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
    92655 PROCEDURAL STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

    Patients

    Seq Age Sex Outcome Treatment
    1