BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 FRAME

    MDR report key: 18652997 · Received February 6, 2024

    Report

    Report Number
    3006697241-2024-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 11, 2024
    Report Date
    February 6, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE SIDERAIL WIRING HARNESS 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 BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE SIDERAIL WIRING HARNESS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE HEAD AND FOOT SECTIONS WERE GOING UP WHEN SIDERAILS WERE LOWERED. 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
    2086439 ADVANTA 2 FRAME BED, MANUAL FNJ HILL-ROM MEXICO P1190A000253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown