BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 3881046 · Received April 8, 2014

    Report

    Report Number
    2020362-2014-00119
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    March 3, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT THE ALARM SOUNDS INTERMITTENTLY WHEN IN USE WITH THE CHAIR BELT SENSOR. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211813 POSEY KEEPSAFE DELUXE KMI KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MOBILE CHAIR BELT SENSOR, MODEL 8371, LOT# UNKNOWN