BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE FRAME

    MDR report key: 9875870 · Received March 24, 2020

    Report

    Report Number
    1824206-2020-00138
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 19, 2020
    Report Date
    March 19, 2020
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILLROM TECHNICIAN FOUND THE EXTERNAL ALARM NEEDED TO BE REPLACED. THE EXTERNAL ALARM IS THE SOURCE OF THE BRAKE NOT SET ALARM. PER THE HILLROM SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE® BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. MAKE SURE THE BRAKE IS NOT SET, AND THEN PLUG THE BED INTO AN APPLICABLE POWER SOURCE. A STEADY ALARM COMES ON. SET THE BRAKE. THE ALARM STOPS. REPAIR OR REPLACE AS NECESSARY. A SEARCH OF THE HILLROM MAINTENANCE RECORDS SHOWED HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JULY 2019. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE EXTERNAL ALARM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED HAD NO AUDIBLE BRAKE NOT SET ALARM. THE BED WAS LOCATED IN 8 NORTH 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
    339586 VERSACARE FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P3200K000004

    Patients

    Seq Age Sex Outcome Treatment
    1