BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL ROM ICU BED

    MDR report key: 6360154 · Received February 27, 2017

    Report

    Report Number
    6360154
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 7, 2017
    Manufacturer
    HILL-ROM, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE INSPECTION BY MATERIALS MANAGEMENT, DEFECTIVE WELDS WERE FOUND ON HILL-ROM ICU BED MODEL TC66. CLINICAL ENGINEERING SECURED THE BED, PENDING FURTHER INSPECTION. THIS WAS FOUND DURING A ROUTINE INSPECTION. NO PATIENT WAS INVOLVED. MANUFACTURER RESPONSE FOR HILL-ROM ICU BED MODEL TC66, HILL ROM ICU BED (PER SITE REPORTER): WE ARE ARRANGING AN INSPECTION BY THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144375 HILL ROM ICU BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM, INC TC66

    Patients

    Seq Age Sex Outcome Treatment
    1 NO- PATIENT WAS NOT INVOLVED, THIS DEFECT WAS FOU