BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 19464123 · Received June 4, 2024

    Report

    Report Number
    3006697241-2024-00046
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 4, 2024
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE HILLROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. 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. ¿ ANY SIGNS OF DAMAGE TO THE CABLE. ¿ ANY EXPOSED WIRES. REPLACE THE POWER CORD, IF DAMAGED. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN APR 1, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. 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 BAXTER TECHNICIAN STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174975 CAREASSIST ES120/220/420 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170G0000297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown