BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 8560338 · Received April 29, 2019

    Report

    Report Number
    3006697241-2019-00032
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 17, 2019
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED'S HEAD RIGHT CASTER WAS DAMAGED AND NEEDED TO BE REPLACED. PER THE HILL-ROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. CHECK THE BRAKES TO SEE WHETHER THE BED MOVES WHEN THE BRAKE PEDALS ARE PRESSED AND REPAIR AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE HEAD RIGHT CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BED WOULD STILL ROLL WHEN THE BED WAS IN BRAKE MODE (THE BRAKES WOULD NOT HOLD). THE BED WAS LOCATED NEAR THE BED SHOP 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
    355039 CAREASSIST ES120/220/420 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170G0000297

    Patients

    Seq Age Sex Outcome Treatment
    1