BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA 2 FRAME

    MDR report key: 18878102 · Received March 11, 2024

    Report

    Report Number
    3006697241-2024-00017
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 11, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE POWER CORD 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 PLUG FOR DAMAGE. MAKE SURE THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY. IF IT IS NOT, REPLACE THE PLUG CORD ASSEMBLY. REPLACE ANY PLUG CORD ASSEMBLY THAT SHOWS ANY OF THESE: DISCOLORATION OF THE PLUG MOLDING AROUND THE PLUG BLADES; THIS COULD OCCUR IF THE PLUG BLADES HAVE OVERHEATED OR ARCED. ANY SIGNS OF CRACKING; THIS COULD OCCUR IF THE PLUG HAS BEEN BENT AND STRAIGHTENED TO A POINT PAST ITS USEFUL LIFE. LOOSE FIT OF THE PLUG BLADE (THE PLUG BLADE MOVES IN THE MOLDING); THIS COULD OCCUR IF THE MOLDING HAS OVERHEATED OR THE BLADES HAVE BEEN BENT AND STRAIGHTENED TO A POINT PAST THEIR USEFUL LIFE. REPLACE THE POWER CORD, IF DAMAGED. 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 POWER CORD 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 CUSTOMER STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. 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
    2010622 ADVANTA 2 FRAME BED, MANUAL FNJ HILL-ROM MEXICO P1190A000219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown