BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3190186 · Received June 10, 2013

    Report

    Report Number
    2020362-2013-00252
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 23, 2013
    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

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. THE UNIT POWERED UP WITH NEW BATTERIES AND THE LOW BATTERY INDICATOR DOES NOT SOUND WHEN IT SHOULDN'T. ALTHOUGH THE UNIT PASSED ALL FUNCTIONAL TESTS, A BATTERY SPRING IS BADLY BENT. NOTE: INSTRUCTIONS FOR USE FOR BATTERY INSTALLATION STATES: HOLD ALARM VERTICALLY UPSIDE DOWN TO PREVENT THE BATTERY SPRINGS FROM BENDING DURING BATTERY INSTALLATION. AFTER CHANGING BATTERIES, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LOW BATTERY INDICATOR CONTINUOUSLY SOUNDS. CUSTOMER REPLACED BATTERIES DAILY TO ENSURE THAT THE ALARM WILL FUNCTION PROPERLY TO PREVENT A FALL. CUSTOMER DID NOT KNOW WHEN THE ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261964 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA