BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 8248567 · Received January 15, 2019

    Report

    Report Number
    2020362-2018-00177
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Report Date
    December 18, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED AND ANALYZED BY THE MANUFACTURER. THE DEVICE WAS RECEIVED IN WITH INDENTATIONS TO THE EXTERIOR HOUSING. DAMAGES TO THE BATTERY COMPARTMENT WERE ALSO NOTED DURING THE VISUAL INSPECTION. ANALYSIS OF THE DEVICE FOUND THE FAILSAFE FEATURE IS NOT WORKING AS IT DOES NOT SOUND PROPERLY WHEN NOTHING WAS ATTACHED TO THE UNIT. INSPECTION OF THE ALARM REVEALED A DAMAGED CAPACITOR TO BE THE CAUSE OF THE FAILURE. BASED ON THE AGE OF THE DEVICE, IT¿S POSSIBLE NORMAL WEAR AND TEAR 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 (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 WARRANT. MANUFACTURER REFERENCE FILE : (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DID NOT ALARM WHEN THE PATIENT GOT UP. THERE WAS NO INJURY TO THE PATIENT. WHEN THE ALARM IS SUPPOSE TO ALARM IT CHIRPS ONCE. THE BATTERIES HAVE BEEN REPLACED. UNIT IS STILL ONLY CHIRPING ONCE WHEN THE ALARM IS SUPPOSED TO SOUND. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40498 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1