BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA2 RENTAL BED

    MDR report key: 18716158 · Received February 15, 2024

    Report

    Report Number
    3006697241-2024-00015
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 15, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE HEAD ACTUATOR 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. EXAMINE THE HANDLES, CABLES, AND CPR MECHANISM ON THE HEAD MOTOR. MAKE SURE THE SCREWS ARE INSTALLED AND FULLY TIGHTENED. RAISE THE HEAD SECTION TO THE HIGH POSITION, THEN ACTIVATE ONE OF THE CPR RELEASES. MAKE SURE THE HEAD SECTION LOWERS. ADJUST THE CPR CABLE AS NECESSARY. DO THE SAME TEST ON THE OTHER SIDE OF THE BED. RELEASE THE CPR HANDLES AND MAKE SURE THE MECHANISM LOCKS CORRECTLY BY OPERATING THE HEAD UP CONTROL FOR A FEW SECONDS. THE HEAD SECTION SHOULD RISE. REPLACE THE HEAD SECTION MOTOR AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN (B)(6) 2023. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE HEAD ACTUATOR 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 CPR WAS NOT WORKING AND COULD NOT BE OPERATED. 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
    2162630 ADVANTA2 RENTAL BED BED, MANUAL FNJ HILL-ROM MEXICO P1190ARENT01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown