BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE FRAME

    MDR report key: 7623312 · Received June 20, 2018

    Report

    Report Number
    1824206-2018-00241
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR'S SERVICE ENGINEER FOUND THE LEFT AND RIGHT FOOT CONTROL ASSEMBLIES NEEDED TO BE REPLACED. PER THE HILL-ROM SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE® BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. 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. THE ENGINEER REPLACED THE LEFT AND RIGHT FOOT CONTROL ASSEMBLIES TO RESOLVE THE ISSUE. 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 HEAD OF THE BED WOULD GO UP ON ITS OWN. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465293 VERSACARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P3201K000495

    Patients

    Seq Age Sex Outcome Treatment
    1