BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE MED SURG BED

    MDR report key: 21347010 · Received February 10, 2025

    Report

    Report Number
    1824206-2025-00245
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 10, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. 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. ANY SIGNS OF CRACKING., LOOSE FIT OF THE PLUG BLADE (THE PLUG BLADE MOVES IN THE MOLDING), VERIFY THAT THE STRAIN RELIEF P-CLIP IS PRESENT. REPLACE THE POWER CORD, IF DAMAGED. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN NOV 14, 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

    IT WAS REPORTED THAT VERSACARE FRAME (PRODUCT CODE P3200K000574, SERIAL NUMBER (B)(6), HAD POWER CORD CUT IN HALF DUE TO ABUSE. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609704 VERSACARE MED SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P3200K 00887761000872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.