BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2490612 · Received March 6, 2012

    Report

    Report Number
    2020362-2012-00136
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Report Date
    February 7, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - VOICE MESSAGE, STATIC, UNLABELED. RESULTS - EVAL OF THE RETURNED PRODUCT FOUND THE NURSE CALL LIGHT TURNS OFF INTERMITTENTLY WHEN THE NURSE CALL CABLE IS WIGGLED. THE NURSE CALL CABLE FITS SECURELY IN THE RECEPTACLE. THE VOICE MESSAGE SOUNDS LIKE STATIC. TONE SOUNDS NORMALLY. THERE IS NO PHYSICAL DAMAGE OBSERVED TO THE ALARM UNIT. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: ALWAYS CHECK TO ENSURE STAFF CAN HEAR ALARM AT THE FURTHER POSSIBLE DISTANCE BEFORE LEAVING PT UNATTENDED. WHEN CONNECTING THE ALARM TO THE NURSE CALL SYSTEM, CHECK THAT THE NURSE CALL CABLE IS SECURELY CONNECTED TO THE ALARM AND THE NURSE CALL PANEL. ALWAYS TEST ALARM AND NURSE CALL FUNCTION IF NURSE CALL CABLE IS PLUGGED INTO THE ALARM INTO THE ALARM AND WALL JACK. ACTIVATE THE ALARM (REMOVE PRESSURE FROM SENSOR, UNFASTEN CHAIR BELT SENSOR, OR ACTIVATE PIR SENSOR) AND MAKE SURE THE NURSE CALL LIGHT FOR THE PROPER BED AND NOON ACTIVATE IN THE APPROPRIATE NURSE'S STATION LOCATION. REMOVE THE CABLE FROM THE WALL JACK AND MAKE SURE THE VISUAL OR AUDIBLE ALERT AT THE NURSE'S STATION IMMEDIATELY ACTIVATES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE VOICE TONE HAS STATIC. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY COMPANY 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA