BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 FRAME

    MDR report key: 18608190 · Received January 30, 2024

    Report

    Report Number
    3006697241-2024-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 30, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE¿RIGHT CABLE AND CAREGIVER MEMBRANE NEEDED TO BE REPLACED. PER THE HILLROM SERVICE MANUAL THE ADVANTA¿ 2 SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. THIS¿WILL HELP MAKE SURE OF A LONG, OPERATIVE LIFE FOR THE ADVANTA¿ 2 BED. THE PREVENTATIVE MAINTENANCE WILL HELP TO REDUCE DOWNTIME DUE TO EXCESSIVE WEAR FAILURES. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. MAKE SURE THE HEAD AND FOOT SIDE RAILS ARE NOT BENT OR TWISTED. MAKE SURE THE LATCH MECHANISM OPERATES CORRECTLY. AN AUDIBLE CLICK MUST BE HEARD. REMOVE THE SIDE RAIL COVER, AND MAKE SURE THE MOUNTING SCREWS ARE TIGHT. INSPECT THE CABLE ROUTING FOR PINCHING, BINDING, AND DAMAGE. MAKE SURE ALL FUNCTIONS ON THE CAREGIVER CONTROL OPERATE CORRECTLY.REPAIR OR REPLACE THE SIDE RAIL AS 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 RIGHT CABLE AND CAREGIVER MEMBRANE 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 BED FUNCTIONS SELF-RUN WHEN RAISING RIGHT SIDERAIL. 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
    2538544 ADVANTA 2 FRAME BED, MANUAL FNJ HILL-ROM MEXICO P1190A000109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown