BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 11619895 · Received April 6, 2021

    Report

    Report Number
    2020362-2021-00019
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Report Date
    March 12, 2021
    Manufacturer
    POSEY PRODUCTS, LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS DISCARDED AS IT PASSED ITS USEFUL LIFE. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT DATABASE REVEALED SIMILAR COMPLAINTS OF 8345 ALARMS EITHER SOUNDING WHEN THEY SHOULDN¿T OR NOT SOUNDING WHEN THEY SHOULD. INVESTIGATIONS INTO THESE COMPLAINTS REVEALED THAT THE MOST LIKELY CAUSE OF THE REPORTED COMPLAINT IS EITHER DAMAGE TO THE SENSOR RECEPTACLE OR DAMAGE TO THE RJ-11 CLIP. DAMAGE CAN CAUSE THE PINS INSIDE THE SENSOR RECEPTACLE TO BECOME STUCK DOWN, EITHER TRIGGERING NO ALARM OR FALSE ALARM. IT CAN ALSO CAUSE THE SENSOR CABLE TO NOT HAVE A SECURE FIT IN THE RECEPTACLE, WHICH CAN ALLOW MOVEMENT TO AFFECT FUNCTION. LIKEWISE WITH DAMAGE TO THE SENSOR CABLE CLIP. OTHER CAUSES, SUCH AS CORROSION AND MOISTURE DAMAGE, ARE ALSO A POSSIBILITY. BEING THAT THE UNIT IS OVER SIX YEARS OLD, IT IS LIKELY THAT NORMAL WEAR AND TEAR THAT CONTRIBUTED TO THE REPORTED ISSUE. 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. MANUFACTURER REFERENCE FILE NUMBER (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2021 BD1 CUSTOMER CONTACTED US VIA PHONE CALL. THE CUSTOMER HAS AN ALARM THAT IS OVER 4 YEARS OLD. S/N (B)(4). CUSTOMER HAS BEEN INFORMED OF THE 4 YEAR USEFUL LIFE POLICY. ALARM WILL TURN ON BUT WILL NOT ARM WITH A SENSOR PAD ATTACHED. WE WILL REPLACE THE ALARM FOR THEM BUT WE ARE NOT BRINGING IT IN FOR INSPECTION DUE TO ITS AGE. NO GTIN INFORMATION IS AVAILABLE. A TS TEMPLATE HAS BEEN COMPLETED AND SAVED TO THE DRIVE. SINCE THIS IS AN APA CUSTOMER THEY HAVE BEEN INSTRUCTED TO DESTROY THE ALARM AND PROVIDE PROOF. 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
    520048 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS, LLC 8345 1433KF1202

    Patients

    Seq Age Sex Outcome Treatment
    1