BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 3770301 · Received February 18, 2014

    Report

    Report Number
    2020362-2014-00050
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    December 18, 2013
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT FOUND THAT THE UNIT HAS BENT BATTERY SPRINGS, THERE ARE SIGNS OF WATER INTRUSION AND THE CASE IS CHIPPED NEAR THE BATTERY DOOR. THE UNIT POWERS ON AND PASSES FUNCTIONAL TESTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER DID NOT SPECIFY THE PROBLEM WITH THE ALARM. ADDITIONAL INFORMATION RECEIVED WITH THE ALARM IS "BROKEN: ALARM NOT WORKING PROPERLY". CUSTOMER DID NOT PROVIDE A DATE WHEN ISSUE WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101181 POSEY SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SITTER SELECT MAGNET PART #8361M, LOT# UNK