BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELIT

    MDR report key: 4180377 · Received October 15, 2014

    Report

    Report Number
    2020362-2014-00333
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 2, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE ALARM FOUND THERE IS A NOTE ON THE UNIT STATING "KEEP BEEPING". THE NOTE ON THE UNIT IS NOT CONFIRMED, THE UNIT DOES NOT SOUND CONTINUOUSLY WHEN IN USE WITH THE PULL MAGNET. THE PRE-RECORDED VOICE MESSAGE DOES NOT PLAY - ONLY A CLICKING SOUND IS HEARD WHEN WEIGHT IS REMOVED FROM THE SENSOR OR WHEN THE PULL MAGNET IS REMOVED WHEN IS DUE TO A DEFECTIVE VOICE CHIP. THE TONE PLAYS PROPERLY. NO PHYSICAL DAMAGE OBSERVED TO THE UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM IS NOT FUNCTIONING PROPERLY. CUSTOMER HAS LIMITED INFO. CUSTOMER COULD NOT PROVIDE THE DATE OF EVENT. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655373 POSEY SITTER ELIT KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAGNET: 8345M