BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM 405 ELECTRIC BED

    MDR report key: 2192011 · Received July 29, 2011

    Report

    Report Number
    3006697241-2011-00066
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: FIRST OCCURRENCE- MONITOR FIELD PERFORMANCE. THE DISTRIBUTOR STATED THEY PERFORMED SOME CHECKS WITH A DEVICE TO VERIFY THE STATIC ENERGY OF THE BED. THE RESULTS WERE NEGATIVE AND SHOWED THIS IS NOT THE REASON FOR THE SHOCKS. THEN THE POSSIBILITY OF THESE SHOCKS BEING GENERATED BY STATIC ELECTRICITY FROM THE MATTRESSES WAS THEN DISCARDED. THE INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES USERS AT THE HOSPITAL ARE COMPLAINING ABOUT SMALL ELECTRIC SHOCKS WHEN TOUCHING THE BED, ESPECIALLY WHEN THEY TOUCH THE IV POLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL-ROM 405 ELECTRIC BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1440B

    Patients

    Seq Age Sex Outcome Treatment
    1