BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 8248637 · Received January 15, 2019

    Report

    Report Number
    2020362-2019-00011
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Report Date
    November 28, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL FINDINGS REVEALED BOTH DUST COVERS UNDERNEATH THE BATTERY SLOTS HAVE BEEN DAMAGED. A PIN INSIDE THE NURSE CALL RECEPTACLE WAS BENT DOWN. EVALUATION FOUND THE UNIT DID NOT SEND A SIGNAL TO ACTIVATE THE INDICATOR LIGHT AT THE NURSE CALL TEST FIXTURE DUE TO A DAMAGED NURSE CALL RECEPTACLE. BEING THAT THE UNIT IS MORE THAN FOUR YEARS OLD, THE LIKELY CAUSE OF THE EVENT IS EXPECTED NORMAL WEAR AND TEAR. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE, WHEN USING A NURSE CALL CABLE, ENSURE THE NURSE CALL CABLE IS PLUGGED IN TO BOTH THE ALARM AND THE WALL JACK BEFORE LEAVING THE PATIENT UNATTENDED. VERIFY THAT AN ALERT IS RECEIVED AT THE NURSING STATION IF THE CABLE IS UNPLUGGED FROM THE WALL JACK. THERE WILL BE NO ALERT AT THE NURSING STATION OR AT THE BEDSIDE IF THE NURSE CALL CABLE IS UNPLUGGED FROM THE ALARM. IF THE NURSE CALL CABLE IS UNPLUGGED FROM THE ALARM WHEN IT IS IN VOICE ONLY OR MUTE MODE, THE ALARM WILL DEFAULT TO VOICE AND TONE AS A FAILSAFE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM IS NOT FUNCTIONING. FURTHER INVESTIGATION FOUND THE UNIT DOES NOT SEND A SIGNAL TO THE NURSE'S STATION. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41918 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1