BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE P500 AIR RENTAL BED

    MDR report key: 3932259 · Received April 4, 2014

    Report

    Report Number
    1824206-2014-01098
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THAT THE RIGHT FRONT BRAKE WAS OUT OF ADJUSTMENT WHICH WAS MOST LIKELY DUE TO NORMAL WEAR AND TEAR. THE SERVICE TECHNICIAN ADJUSTED THE RIGHT FRONT BRAKE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE BRAKES WILL NOT LOCK SECURELY WHEN THE BRAKES ARE SET. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205660 VERSACARE P500 AIR RENTAL BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1