BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 12520544 · Received September 23, 2021

    Report

    Report Number
    3006697241-2021-00082
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 19, 2020
    Report Date
    September 23, 2021
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILLROM TECHNICIAN FOUND THE RIGHT SIDERAIL CABLE NEEDED TO BE REPLACED. PER THE HILLROM 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. HILOW COLUMNS: INSPECT THE COLUMN ASSEMBLY FOR THE PRESENCE AND TIGHTNESS OF THE ATTACHMENT SCREWS AND THE SNAP RING AT THE BOTTOM OF THE COLUMN. REPAIR AS NECESSARY. FULLY RAISE AND LOWER THE BED FRAME ONE TIME. MAKE SURE THERE IS NO FRICTION OR ABNORMAL NOISES AND THAT NO AUDIBLE OVERLOAD INDICATION CAN BE HEARD DURING THE MOVEMENT. MAKE SURE THE BED NOT DOWN POSITION INDICATOR ILLUMINATES ON THE CONTROL PENDANT AND GOES OUT WHEN THE BED IS IN THE LOW POSITION. REPLACE THE DEFECTIVE COLUMN(S) IN THE EVENT OF A MALFUNCTION. TROUBLESHOOT IN THE EVENT OF A DOUBT. 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 RIGHT SIDERAIL CABLE 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 WAS MOVING ON ITS OWN. 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
    1416497 CAREASSIST ES120/220/420 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170G0000228

    Patients

    Seq Age Sex Outcome Treatment
    1