BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA FRAME

    MDR report key: 17301822 · Received July 11, 2023

    Report

    Report Number
    1824206-2023-00735
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 11, 2023
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    UDI-DI
    00887761000100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE CASTERS NEEDED TO BE REPLACED. PER THE PROGRESSA USER MANUAL: THE BRAKE NOT SET IS AN AUDIBLE AND VISUAL ALARM. THE ALARM WILL SOUND, AND A MESSAGE WILL SHOW ON THE GCI, WHEN THE BED IS CONNECTED TO AN AC POWER SOURCE AND THE BRAKE IS NOT SET. WHEN THE BED IS CONNECTED TO AC POWER AND THE BRAKES ARE NOT SET, AN ALARM SOUNDS AND A MESSAGE SHOWS ON THE GCI. WHEN AC POWER IS REMOVED, THE ALARM WILL STOP AND THE GCI WILL TURN OFF. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE CASTERS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED BRAKES WERE NOT HOLDING. 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
    1687945 PROGRESSA FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7500A000131 00887761000100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown