BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3856462 · Received April 18, 2014

    Report

    Report Number
    2020362-2014-00155
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 12, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF RETURNED ALARM CONFIRMED THE REPORTED ISSUE. HOWEVER, WHEN THE NURSE CALL FUNCTION WAS TESTED, THE LED LIGHT DOES NOT COME ON AT THE NURSE CALL TEST FIXTURE AS IT SHOULD. NO PHYSICAL DAMAGES FOUND TO THE ALARM UNIT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE ALARM IS SOUNDING AND THE HOLD BUTTON IS PUSHED, THE ALARM CONTINUES TO SOUND. THE CUSTOMER DID NOT KNOW WHEN THIS WAS DISCOVERED OR THE DATE WHEN THE ISSUE WAS FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238826 SITTER SELECT KMI J. T. POSEY COMPANY 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT # UNK| 30-DAY OVER MATTRESS BED SENSOR: MODEL: 8283,