BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1886032 · Received October 26, 2010

    Report

    Report Number
    2020362-2010-00316
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    September 30, 2010
    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

    (B)(4). (OTHER) LCD DISPLAY IS UNCLEAR. EVAL RESULTS (OTHER) - THE ALARM HAS POWER, BUT THE LCD DISPLAY IS ONLY PARTIALLY VISIBLE. ONLY THE FOLLOWING FUNCTIONS CAN BE VERIFIED AS WORKING SINCE THEY DO NOT REQUIRE THE USER TO LOOK AT THE SCREEN TO TEST: BOTH SENSOR RECEPTACLES, FAIL SAFE, HOLD, RECORD, PLAY, POWER BUTTON AND LOW BATTERY INDICATOR. OVERALL - THE SCREWS ARE RUSTED. THE ALARM CASE IS DAMAGED ON THE BOTTOM RIGHT CORNER. THE BATTERY DOOR CONTACT HAS RUST. THE LIQUI LABEL DOES NOT SHOW MOISTURE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THE ALARM HAS POWER, BUT THE LCD DISPLAY IS UNCLEAR WHEN USED WITH AN (B)(4). CUSTOMER DETECTS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM CASE. THE ISSUE WAS IDENTIFIED DURING SETUP IN THE WAREHOUSE AND NO PT CONTACT. INSPECTION OF THE PRODUCT SHOWS THAT THE BATTERY DOOR CONTACTS HAVE RUST ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SENSOR PAD: MODEL 8307, LOT# UNK