BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEGANZA

    MDR report key: 2929906 · Received December 31, 2012

    Report

    Report Number
    2929906
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    April 11, 2012
    Report Date
    December 31, 2012
    Manufacturer
    LINET AMERICAS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS LOWERING SIDE RAIL OF BED. A METAL PIECE (BOLT?) POPPED OUT OF/BROKE OFF THE RIGHT SIDE OF THE BED. THE HEAD OF THE BED DROPPED FROM 30 DEGREES TO FLAT. TOP HALF OF BED WAS THEN NOTED TO BE ABLE TO ROCK BACK AND FORTH SIDEWAYS WHEN THE SIDE RAIL WAS TOUCHED. NO INJURY TO PATIENT OR EMPLOYEE. MANUFACTURER WAS NOTIFIED AND REPLACED THE BED. THE AGE OF THE BED IS UNKNOWN: THE BED WAS ON LOAN (TRIAL BED) FROM THE MANUFACTURER.======================MANUFACTURER RESPONSE FOR HOSPITAL BED- LINET ELEGANZA 3 BED, LINET ELEGANZA 3 BED (PER SITE REPORTER).======================MANUFACTURER APOLOGIZED. THE MFG REP RETRIEVED THE BROKEN BED AND REPLACED IT WITH ONE THAT WASN'T BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEGANZA BED, ADJUSTABLE FNL LINET AMERICAS ELEGANZA 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO OTHER THERAPIES