BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES100/200/400

    MDR report key: 10884865 · Received November 23, 2020

    Report

    Report Number
    3006697241-2020-00082
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. 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. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE REPAIR, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED HEAD SECTION WAS LOWERING 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
    1347530 CAREASSIST ES100/200/400 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO U1170G0000042

    Patients

    Seq Age Sex Outcome Treatment
    1