BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 11690069 · Received April 19, 2021

    Report

    Report Number
    2020362-2021-00020
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    March 25, 2021
    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

    THE DEVICE WAS RECEIVED IN WITH BENT PIN 3 INSIDE THE NURSE CALL RECEPTACLE. SCUFF MARKS OBSERVED ABOVE THE SENSOR PINS INSIDE THE SENSOR RECEPTACLES. ONE OF THE MOUNTING SLOTS IS BENT, OR THE UNIT APPEARED TO BE PULLED AWAY FROM WHERE IT WAS MOUNTED. TESTING OF THE UNIT CONFIRMED THE REPORTED ISSUE OF THE ALARM NOT SENDING TO THE NURSE CALL STATION DUE TO A FAULTY NURSE CALL RECEPTACLE. THIS LOSS OF FUNCTIONALITY WOULD RESULT IN THE ALARM¿S FAILURE TO ALERT THE CAREGIVER OF A PATIENT EXIT AND COULD CONTRIBUTE TO A PATIENT INCIDENT. BASED ON THE VISUAL FINDINGS, IT IS LIKELY THAT NORMAL WEAR AND TEAR CONTRIBUTED TO THE FAULTY NURSE CALL RECEPTACLE. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES, TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR MAGNET IS REMOVED FROM FACE PLATE. 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 WARRANTED. MANUFACTURER REFERENCE FILE NUMBER 2021-00304.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED US VIA PHONE CALL. THE CUSTOMER HAS AN ALARM THAT STOPPED WORKING WITH THEIR NURSE CALL SYSTEM. HAS BEEN TESTED AT MULTIPLE BEDS VS AN ALARM THAT WORKED WITH THAT BED. SAME RESULT AT EACH BED THE ALARM DOES NOT TRIGGER THE NURSE CALL SYSTEM. NO APPARENT DAMAGE WITHIN THE NC PORT, SENSOR PORT, OR THE BATTERY COMPARTMENT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586450 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS, LLC 8345 1921KF0780

    Patients

    Seq Age Sex Outcome Treatment
    1