BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 FRAME

    MDR report key: 12350384 · Received August 20, 2021

    Report

    Report Number
    3006697241-2021-00071
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 29, 2021
    Report Date
    July 29, 2021
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILLROM TECHNICIAN FOUND THE SIDERAIL CABLE ASSY NEEDED TO BE REPLACED. PER THE HILLROM SERVICE MANUAL THE ADVANTA" 2 SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. TEST EACH OF THE BUTTONS TO CHECK THAT THEY ACTIVATE THE CORRECT FUNCTION AND THAT THEY DO NOT WORK INTERMITTENTLY BY PRESSING EACH BUTTON FOR SEVERAL SECONDS. EACH MOVEMENT MUST BE CONTINUOUS. REPLACE THE PENDANT IF NECESSARY. A SEARCH OF THE HILLROM MAINTENANCE RECORDS SHOWED HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN OCTOBER 6TH 2020. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN HAS ORDER AND WILL REPLACED THE SIDERAIL CABLE (PART#141806) 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 HEAD OF THE BED WAS MOVING ON IT'S OWN. THE BED WAS LOCATED 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
    1245893 ADVANTA 2 FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1190A000072

    Patients

    Seq Age Sex Outcome Treatment
    1