BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 8299142 · Received February 1, 2019

    Report

    Report Number
    2020362-2019-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Report Date
    January 8, 2019
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL FINDINGS REVEALED THE LED COVER HAD BEEN PUSHED DOWN INTO THE UNIT AS IT WAS NO LONGER ATTACHED ON THE UPPER ENCLOSURE. EVALUATION OF THE UNIT FOUND THAT THE UNIT DID NOT SEND A SIGNAL TO ACTIVATE THE LIGHT AT THE NURSE CALL TEST FIXTURE WHEN WEIGHT WAS REMOVED FROM THE SENSOR PAD DUE TO A BROKEN NURSE CALL RELAY. BEING THAT THE UNIT IS MORE THAN THREE YEARS OLD, IT IS LIKELY THE CAUSE OF THE MALFUNCTION, IS 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. 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 WHEN THE ALARM IS IN USE WITH THE NURSE CALL CABLE THE ALARM DOES NOT SEND SIGNAL TO THE NURSES STATION WHEN THE PATIENTS WEIGHT IS REMOVED FROM THE SENSOR PAD. 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
    91823 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8374

    Patients

    Seq Age Sex Outcome Treatment
    1