BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE FALL MONITOR

    MDR report key: 3856471 · Received April 18, 2014

    Report

    Report Number
    2020362-2014-00157
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 24, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS SUBMITTED BASED ON THE CUSTOMERS REPORTED ISSUE STATEMENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER, BUT DOES NOT SOUND. THE BATTERIES HAVE BEEN REPLACED AND NO VISIBLE DAMAGE WAS REPORTED. THE ISSUE WAS DISCOVERED DURING SETUP, BUT THE DATE IS UNKNOWN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238827 KEEPSAFE FALL MONITOR KMI J. T. POSEY COMPANY 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BED SENSOR PAD: MODEL 8307, LOT #UNK.