BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 4203569 · Received September 17, 2014

    Report

    Report Number
    1824206-2014-02279
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT SUGGESTED ISOLATING THE LOAD BEAMS. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THEIR BEDS. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER, IF ANY ADDITIONAL RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE SCALE WAS READING INACCURATE WEIGHTS. THE BED WAS LOCATED IN THE BED SHOP AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYS AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575347 VERSACARE BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1