BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II

    MDR report key: 1821297 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00183
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    June 30, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE NURSE CALL FUNCTIONS INTERMITTENTLY. THE BATTERY LIGHT CAME ON, BUT IS DIM. THE ALARM CASE IS DAMAGED ON THE BOTTOM RIGHT CORNER. MANUFACTURER REFERENCES (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM IS READING LOW BATTERY EVEN WITH NEW BATTERIES. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS THE NURSE CALL FUNCTIONS INTERMITTENTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI