BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7728410 · Received July 27, 2018

    Report

    Report Number
    2020362-2018-00064
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    June 20, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: NI. ANALYSIS OF THE DEVICE WAS NOT ABLE TO CONFIRM THE REPORTED FAILURE OF NO POWER. THE DEVICE POWERED UP WITH BATTERIES INSTALLED. HOWEVER, DURING TESTING OF THE UNIT, IT WAS NOTED THE ALARM WOULD NOT SEND A SIGNAL TO THE NURSE CALL STATION. THIS FAILURE WAS DUE TO BROKEN PINS AT THE NURSE CALL RECEPTACLE. THE DEVICE PASSED ALL OTHER FUNCTIONAL TESTING. AS THE PRODUCT WAS MANUFACTURED OVER 2 YEARS AGO, IT'S POSSIBLE NORMAL WEAR AND TEAR COULD HAVE CONTRIBUTED TO THE FAILURE. 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 WARRANTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT POWER ON. NEW BATTERIES WERE INSTALLED AND ALARM STILL WILL NOT POWER ON. THE DATE THE ISSUE WAS DISCOVERED IS NOT KNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570083 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1