BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 2840060 · Received November 8, 2012

    Report

    Report Number
    3006697241-2012-00266
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 18, 2012
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT UNPLUGGED THE SIDE RAIL AND THE TRENDELENBURG FUNCTIONS WOULD NOT OPERATE AT ALL. THE ACCOUNT RECONNECTED BOTH SIDE RAILS AND AGAIN ALLEGED THAT NEITHER TRENDELENBURG FUNCTION WILL WORK. THE ACCOUNT REPLACED THE SIDE RAIL INTERFACE BOARD TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THAT WHEN HE PRESSES THE TRENDELENBURG SWITCH THE BED WILL ACTUALLY GO INTO REVERSE TRENDELENBURG AND VICE VERSA. NO INJURY REPORTED.

    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