BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1082375 · Received July 25, 2008

    Report

    Report Number
    1824206-2008-02886
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008 - REP ALLEGED THAT A NURSE WAS BENDING DOWN TO PICK SOMETHING UP OFF THE FLOOR AND SHE GRABBED THE INTERMEDIATE SIDERAIL OF THE TC BED AND THE SIDERAIL PULLED DOWN ON HER, CONTACTING HER. REP ALLEGED THAT THE NURSE WAS NOT SERIOUSLY INJURED. REP ALLEGED THAT THE SIDERAIL WILL RAISE AND APPEAR LATCHED BUT THEN GIVE WAY. IN 2008 - SUM - TSR REP STATED THAT HE INSPECTED THE SIDERAIL ON THE BED AND FOUND THAT WHEN THE SIDERAIL LATCH IS RELEASED, THE SIDERAIL WILL LOWER SOMETIMES BUT OTHER TIMES WOULD STAY IN THE UP POSITION. TSR REP STATED THAT HE FOUND THE LATCH PIN TO BE CONTAMINATED WITH FLUID RESIDUE, HE CLEANED THE LATCH PIN AND THE SIDERAIL WORKS CORRECTLY. REP, HEALTH AND SAFETY DIRECTOR, ALLEGED THAT THE NURSE INVOLVED IN THE ALLEGED INCIDENT, WENT TO E.R. AND AN PER THE E.R. DOCTOR, THE MRI DETECTED A BULGING DISK. IN MAN112 CHAPTER 6 PREVENTATIVE MAINTENANCE CHECKLIST, SIDERAIL FRAME SHOULD BE CHECKED FOR LATCHING. PREVENTATIVE MAINTENANCE SHOULD BE PERFORMED EVERY 6 MONTHS. MAINTENANCE STATED THAT THEY DO AN ANNUAL SAFETY CHECK ON THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900AF1619

    Patients

    Seq Age Sex Outcome Treatment
    1