BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 1974166 · Received December 30, 2010

    Report

    Report Number
    2020362-2010-00417
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    October 28, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: THE BATTERY SPRINGS ARE BENT. THE BATTERY DOOR IS DAMAGED. THE ALARM CASE IS DAMAGED NEAR THE BATTERY COMPARTMENT. EVAL FOR THE RETURNED PRODUCT SHOWS WHEN TESTED THE ALARM POWERED-UP AND PASSED FUNCTIONAL TESTS. THE POSEY INSTRUCTIONS FOR USE HAS A WARNING: THE 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 THE ALARM SOUNDS CONTINUOUSLY WHEN WEIGHT IS APPLIED TO THE SENSOR. THE ALARM ALSO SOUNDS WHEN THE PULL CORD IS ATTACHED TO THE OUTSIDE OF THE ALARM. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THERE WAS NO PT INCIDENT OR INJURY REPORTED. EVAL FOR THE RETURNED PRODUCT SHOWS THE BATTERY SPRINGS ARE BENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI