BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3842604 · Received February 24, 2014

    Report

    Report Number
    3006697241-2014-00178
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND AFTER SPEAKING WITH THE NURSING STAFF LEARNED THAT THE BED EXIT SYSTEM COULD NOT BE ARMED AT ALL. THE TECHNICIAN FOUND IT WAS DUE TO IMPROPER SCALE CALCULATION LIKELY DUE TO AN IMPROPER ZERO PROCESS, USER ERROR. THE SCALE WAS ZEROED AS OUTLINED IN THE USER MANUAL BY THE TECHNICIAN AND THE BED EXIT SYSTEM OPERATED AS DESIGNED, NO REPAIR NEEDED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE BED EXIT SYSTEM WAS DISARMING AFTER BEING SET. THE BED IS LOCATED IN ROOM 11 AT THE FACILITY. 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
    111847 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1170

    Patients

    Seq Age Sex Outcome Treatment
    1