BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3132189 · Received May 1, 2013

    Report

    Report Number
    2020362-2013-00198
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 4, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN RECEIVED. NOTE: INSTRUCTIONS FOR USE STATE: IF YOU ARE STORING THE SITTER ELITE FOR AN EXTENDED PERIOD OF TIME, YOU SHOULD TURN THE ALARM OFF AND REMOVE THE BATTERIES. BATTERIES START TO CORRODE AFTER AN EXTENDED PERIOD OF TIME. CORRODED BATTERIES WILL DAMAGE THE ALARM AND MAY CAUSE IT NOT TO FUNCTION, OR TO FUNCTION INTERMITTENTLY. (B)(4).

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT A CUSTOMER HAS AN ALARM AND DID NOT REMOVE THE BATTERIES WHEN NOT IN USE. AS A RESULT, THERE APPEARS TO BE SOME VISIBLE BATTERY LEAKAGE IN THE BATTERY COMPARTMENT. IT APPEARS THAT THE BATTERY EXPLODED. THE DATE THE ISSUE WAS DISCOVERED WAS NOT KNOWN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191055 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAGNET 8345M