BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 BED

    MDR report key: 3812555 · Received April 17, 2014

    Report

    Report Number
    3006697241-2014-00363
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND THE BED WAS NOT PLUGGED IN. THE TECHNICIAN PLUGGED THE BED IN AND THE BED EXIT FUNCTIONED AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NO SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON ITS BEDS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT WOULD NOT SET. THE BED WAS LOCATED IN ROOM 560 AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235999 ADVANTA 2 BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1