BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA FRAME

    MDR report key: 12014110 · Received June 16, 2021

    Report

    Report Number
    1824206-2021-00331
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 8, 2021
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILLROM TECHNICIAN FOUND THE EXTERNAL ALARM 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 EXTERNAL ALARM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED HAD NO AUDIBLE BRAKE NOT SET ALARM. 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
    906327 PROGRESSA FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7500A000460

    Patients

    Seq Age Sex Outcome Treatment
    1