BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3915171 · Received May 15, 2014

    Report

    Report Number
    2020362-2014-00186
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 16, 2014
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INVESTIGATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; THE ALARM SOUNDS AS IT SHOULD WHEN TESTED WITH A SENSOR. HOWEVER, THE NURSE CALL LED DID NOT TURN ON WHEN WEIGHT WAS REMOVED FROM THE SENSOR PAD DUE TO A FAULTY NURSE CALL RECEPTACLE. THERE WERE NO PHYSICAL DAMAGES TO THE UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER BUT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY AND NO VISIBLE DAMAGE TO THE UNIT WAS REPORTED. CUSTOMER DID NOT PROVIDE THE DATE WHEN THE ISSUE WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289581 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SINGLE PATIENT CHAIR SENSOR MODEL: 8309, LOT # UNK