BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2061375 · Received March 17, 2011

    Report

    Report Number
    2020362-2011-00077
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    J. T. POSEY COMPANY
    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): EVALUATION: RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM DID NOT POWER ON WHEN USING NEW BATTERIES OR AN ALTERNATE POWER SUPPLY. THERE WAS NO VISIBLE DAMAGE TO THE UNIT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS ONCE THE NEW BATTERIES ARE INSERTED THE ALARM HAS POWER BUT IT THEN SLOWLY FADES TO NO POWER. NO OTHER DAMAGE DETECTED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER II KMI J. T. POSEY COMPANY 8281 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI