BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2515893 · Received March 29, 2012

    Report

    Report Number
    2020362-2012-00259
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    January 30, 2012
    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
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED PRODUCT REVEALED THE UNIT POWERED ON AND WAS ABLE TO RECORD A MESSAGE. THERE IS A SOUND IN THE BACKGROUND, BUT THE PRE-RECORDED MESSAGE PLAYS CLEARLY. ADD'L TESTING SHOWS THAT THE MESSAGE DOES RECORD, BUT NOT VERY CLEAR. THE BATTERY SPRINGS ARE BENT. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: THE POSEY SITTER SELECT IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF, BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED, ALARM CASE IS DAMAGED, OR ALARM CASE IS CRACKED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM HAS POWER, BUT WILL NOT ALLOW A MESSAGE TO BE RECORDED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA