BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2112235 · Received April 29, 2011

    Report

    Report Number
    2020362-2011-00130
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    July 14, 2010
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM DOES POWER ON; HOWEVER, IT DOES NOT ALARM WHEN PRESSURE IS OFF THE SENSOR PAD. THERE IS RUST ON THE BATTERY SPRINGS AND THE LIQUI-LABEL SHOWS EXPOSURE TO MOISTURE. THE EVALUATION FINDINGS ARE CONSISTENT WITH THAT OF USER HANDLING RELATED ISSUES AS NOTED IN THE POSEY INSTRUCTIONS FOR USE WHICH 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES. THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM CASE. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI