BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3932842 · Received March 11, 2014

    Report

    Report Number
    2020362-2014-00056
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Report Date
    January 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND A PIN INSIDE THE RJ-11 RECEPTACLE IS LOWER THAN THE REST. WHEN A SENSOR IS PLUGGED INTO THE RECEPTACLE AND THE CABLE ON THE SENSOR IS MOVED, THE ALARM SOUNDS CONTINUOUSLY WHEN THE CABLE IS MOVED, IF THE SENSOR CABLE IS NOT MOVED, THE ALARM WILL SOUND WHEN IT SHOULD. HOWEVER, THERE IS A BENT BATTERY SPRING INSIDE THE BATTERY COMPARTMENT. THE PLASTIC MOLDING ON THE RJ-11 RECEPTACLE IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AREA WHERE THE RJ11 CLIP IS INSERTED INTO THE ALARM HAS A BAD CONNECTION, CUSTOMER HAS LIMITED INFORMATION. CUSTOMER COULD NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146351 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SITTER SELECT MAGNET 8361M