BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3063847 · Received April 3, 2013

    Report

    Report Number
    2020362-2013-00147
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 20, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THERE IS BATTERY LEAKAGE RESIDUE INSIDE THE BATTERY COMPARTMENT. THERE IS NO EVIDENCE OF CORROSION TO THE BATTERY CONTACTS OBSERVED. HOWEVER; THE ALARM POWERS UP AND PASSED ALL FUNCTIONAL TESTS ON ALL THREE ATTEMPTS. THE CUSTOMER'S BATTERIES WERE REC'D AND HAVE EVIDENCE OF LEAKAGE. NOTE: INSTRUCTION FOR USE STATE: ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. DO NOT REPLACE A SINGLE CELL, BUT ALL CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMGE THE ALARM. REMOVE ANY ALARM FROM USE AND SEND TO THE APPROPRIATE FACILITY AUTHORITY IF BATTERIES ARE DAMAGED OR CORRODED OR THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT WILL NOT POWER ON. THE CUSTOMER ALSO REPORTED THAT THEY REPLACED THE BATTERIES WITH A NEW SUPPLY AND THERE IS CORROSION IN THE BATTERY COMPARTMENT. THIS WAS DISCOVERED DURING SET UP PRIOR TO BEING OUT INTO USE WITH A PT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135505 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NURSE CALL CABLE: MODEL: 8282, LOT: NA