BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1914046 · Received November 19, 2010

    Report

    Report Number
    2020362-2010-00367
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 4, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: EVALUATION OF THE PRODUCT FOUND THAT THERE WAS ONE BATTERY SPRING COMPLETELY COVERED BY BATTERY ACID THEREFORE, NO FURTHER TESTS COULD BE PERFORMED. THERE IS NO VISIBLE DAMAGE TO THE ALARM CASE. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: DO NOT MIX OLD AND NEW BATTERIES OR BATTERY BRANDS. THIS MAY CAUSE RUPTURE OR LEAKAGE AND DAMAGE ALARM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES ALL OF THE SAME BRAND AND WITH NEW SENSOR PADS. THERE WAS NO DAMAGE DETECTED BY THE CUSTOMER ON THE ALARM CASE. THIS WAS DISCOVERED DURING SET UP PRIOR TO PLACING IT INTO USE WITH A PATIENT. INSPECTION OF THE PRODUCT FOUND THAT ONE OF THE BATTERY SPRINGS INSIDE THE BATTERY COMPARTMENT IS COMPLETELY COVERED BY BATTERY ACID.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA