BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSA BED

    MDR report key: 3966036 · Received June 3, 2014

    Report

    Report Number
    1824206-2014-01701
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 6, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND TESTED THE BED WAS UNABLE TO DUPLICATE THE ISSUE. THE TECHNICIAN REPLACED THE HAND PENDANT TO TRY AND ISOLATE THE ISSUE. THE INCIDENT REOCCURRED TWO DAYS LATER. HILL-ROM ENGINEER INSPECTED THE BED WAS ABLE TO PUT PRESSURE ON THE HEAD SIDE RAIL AND CAUSE THE HEAD SECTION TO MOVE UPWARDS UNINTENTIONALLY. THE ENGINEER WAS UNABLE TO IDENTIFIED THE ROOT CAUSE OF THE ISSUE. THE BED IS BEING SHIPPED BACK TO HILL-ROM (B)(4). THE BED WAS BROUGHT BACK FOR INSPECTION AND THE ISSUE COULD BE DUPLICATED BY PRESSING AGAINST THE INTERMEDIATE SIDE RAIL TOWARDS THE HEAD END. HILL-ROM ENGINEERING DISASSEMBLED THE RIGHT HEAD SIDE RAIL AND FOUND THE GRAPHIC CAREGIVER INTERFACE CABLE WAS PINCHED AGAINST THE HEAD UP PT SWITCH SOLDER AND THE SOLDER LEADS PIERCED THE GRAPHIC CAREGIVER INTERFACE CABLE SHEATHING INTO THE METAL SHIELD INSIDE THE SHEATH. THE GRAPHIC CAREGIVER INTERFACE WIRE WAS MOVED SO IT IS NOT BEING CONTACTED BY THE SWITCH SOLDER POINTS. ENGINEERING WILL BE REPAIRING THE BED TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE HILL-ROM ACCOUNT EXECUTIVE REPORTED THE BED HAS UNINTENTIONAL BED FUNCTIONS. THE BED WAS LOCATED IN A PT ROOM AND THE PT WAS ON THE BED WHEN THE INCIDENT OCCURRED. THERE WAS NO PT/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
    324950 PROGRESSA BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1