BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES100/200/400

    MDR report key: 8005465 · Received October 25, 2018

    Report

    Report Number
    3006697241-2018-00086
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    September 28, 2018
    Report Date
    September 28, 2018
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM HAS MADE MORE THAN THREE CONTACTS TO INITIATE THE INSURANCE PAPERWORK REQUIRED TO REPAIR THIS BED. 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. 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 PATIENT PERFORMS PREVENTATIVE MAINTENANCE ON THIS BED. HILL-ROM HAS RECEIVED NO RESPONSE TO THESE CONTACTS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED WAS RAISING ON ITS OWN. THE BED WAS LOCATED AT THE PATIENT'S RESIDENCE. 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
    844062 CAREASSIST ES100/200/400 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170E0000042

    Patients

    Seq Age Sex Outcome Treatment
    1