BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVNATA 2 BED

    MDR report key: 3823331 · Received February 28, 2014

    Report

    Report Number
    3006697241-2014-00200
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE SCALE WAS NOT ZEROED BEFORE ATTEMPTING TO SET THE BED EXIT SYSTEM, USER ERROR. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT ALARM SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. THE TECH IN-SERVICED THE ACCOUNT ON THE BED EXIT FUNCTIONS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED EXIT ALARM WILL NOT SET. THE BED IS LOCATED IN 6S HALLWAY 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
    124967 ADVNATA 2 BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1190

    Patients

    Seq Age Sex Outcome Treatment
    1