BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 2851341 · Received November 26, 2012

    Report

    Report Number
    3006697241-2012-00285
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE RIGHT SIDE RAIL SCREWS WERE STRIPPED. THE TECH REPLACED THE RIGHT SIDE RAIL AND LABELS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECH ALLEGED THAT THE RIGHT SIDE RAIL WAS OFF THE BASE OF THE BED AND IS HANGING FROM A WIRE. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1170

    Patients

    Seq Age Sex Outcome Treatment
    1