BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA BED

    MDR report key: 3924703 · Received June 25, 2014

    Report

    Report Number
    1824206-2014-01835
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN THOROUGHLY TESTED AND INSPECTED THE BED AND FOUND NO ISSUES. THE BED ALARMS FUNCTIONED AS DESIGNED. THE PROGRESSA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM BI-ANNUAL PREVENTATIVE MAINTENANCE (PM) AND TESTING FOR JOINT COMMISSION CERTIFICATION. PM AND TESTING NOT ONLY MEET JOINT COMMISSION REQUIREMENTS BUT CAN HELP SUPPORT A LONG, OPERATIVE LIFE FOR THE PROGRESSA BED. PM WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. BASED ON THIS INFORMATION, NO FURTHER INFORMATION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT WILL NOT ALARM. THE BED WAS LOCATED AT THE ACCOUNT IN THE ICU. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369809 PROGRESSA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1