BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II ALARM

    MDR report key: 1974098 · Received December 30, 2010

    Report

    Report Number
    2020362-2010-00414
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    October 19, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: EVAL SHOWS THE RETURNED PRODUCT FAIL SAFE SOUNDS INTERMITTENTLY WHEN THE SENSOR IS UNPLUGGED. PIN # 4 OF SENSOR # 2 RECEPTACLE IS BENT. THERE'S DAMAGE TO THE PLASTIC MOLD OF THE SENSOR # 1 RECEPTACLE. THE ALARM CASE HAS DAMAGE NEAR THE BATTERY COMPARTMENT. NOTE: THE POSEY ALARM IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED (BENT) OR IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT WHEN A SENSOR 8308 IS INSERTED INTO THE FIRST SENSOR RECEPTACLE THE ALARM SOUNDS CONTINUOUSLY WHEN WEIGHT IS APPLIED TO THE SENSOR. WHEN THE RJ-11 CLIP IS INSERTED, IT DOES FIT PROPERLY. THERE IS NO VISIBLE DAMAGE TO THE ALARM. THERE WAS NO PT INCIDENT OR INJURY REPORTED. EVAL SHOWS THE ALARM SOUNDS INTERMITTENTLY WHEN THE SENSOR IS UNPLUGGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SQUARE CHAIR SENSOR PAD, MODEL # 8308, LOT # UNK