BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA BED SYSTEM

    MDR report key: 22955713 · Received September 3, 2025

    Report

    Report Number
    1824206-2025-01508
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FNL
    UDI-DI
    00887761000100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE BED LOWERED BEYOND ITS LIMITS CRUSHING THE POWER CORD BETWEEN THE HEAD ARTICULATION ARM WELDMENT AND LOWER FRAME, CAUSING HEAVY SPARK. BAXTER FIELD SERVICE TECHNICIAN DETERMINED THAT THE CUSTOMER INCORRECTLY CALIBRATED THE BED POSITIONER SENSOR. 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 DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. BAXTER FIELD SERVICE TECHNICIAN CALIBRATED THE BED POSITIONER SENSOR AND THE ACCOUNT 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 STATING THAT , WHILE RUNNING PROGRESSA FRAME DOWN, POWER CORD WAS CUT CAUSING SPARKS. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING BIOMED TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336260 PROGRESSA BED SYSTEM BED, AC-POWERED ADJUSTABLE HOSPITAL FNL BAXTER HEALTHCARE CORPORATION P7500A N/A 00887761000100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown