BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 1923342 · Received December 1, 2010

    Report

    Report Number
    2020362-2010-00383
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    September 22, 2010
    Report Date
    November 3, 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): PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY STATEMENT. (B)(4).

    Description of Event or Problem · 1

    REPORTER SUBMITTED A MEDWATCH FORM THAT THE PATIENT WAS BEING MONITORED ON (B)(6) 2010, BY A SITTER SELECT ALARM AND SENSOR PAD. THE PATIENT WAS FOUND SITTING NEXT TO THE LOW BED AND THE ALARM DID NOT ACTIVATE. THERE WAS NO PATIENT SERIOUS INJURY REPORTED. THE USER FACILITY WAS CONTACTED AND PROVIDED A SERIAL NUMBER CORRECTION FOR THE REPORTED PRODUCT.

    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 76 YR