BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II

    MDR report key: 2112208 · Received April 29, 2011

    Report

    Report Number
    2020362-2011-00136
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    February 17, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE ALARM POWERS ON. WHEN THE PRESSURE IS REMOVED FROM THE SENSOR PAD THE ALARM SOUNDS, THEN THE LCD DISPLAY SHUTS OFF AND THE ALARM STOP SOUNDING. FURTHER TESTING SHOWS THAT THE POWER REGULATOR WAS NOT FUNCTIONAL. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE ALARM POWERS ON THE SCREEN DIMS. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. THE ALARM UNIT HAS NO VISIBLE DAMAGE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI