BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 FRAME

    MDR report key: 18707188 · Received February 14, 2024

    Report

    Report Number
    3006697241-2024-00014
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 14, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE¿HEAD SECTION, CPR CABLE AND HEAD MOTOR 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 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 HEAD SECTION, CPR CABLE AND HEAD MOTOR 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 CABLE WAS BROKEN AND CPR WAS INOPERABLE. 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
    805510 ADVANTA 2 FRAME BED, MANUAL FNJ HILL-ROM MEXICO P1190A000090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown