BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE ASSIST BED

    MDR report key: 3063877 · Received April 3, 2013

    Report

    Report Number
    9615739-2013-00091
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND EVIDENCE OF FLUID THAT HAD LEAKED ON THE SCALE BOARD ASSEMBLY. THE ACCOUNT REPLACED THE SCALE BOARD ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED ALARM WILL NOT TURN OFF. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135703 CARE ASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL 1170

    Patients

    Seq Age Sex Outcome Treatment
    1