BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7863252 · Received September 11, 2018

    Report

    Report Number
    2020362-2018-00121
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Report Date
    August 22, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: THE DEVICE WAS RECEIVED IN WITH SCRATCHES TO THE EXTERIOR HOUSING. MOISTURE INDICATOR LABEL REVEALED THAT THE UNIT WAS EXPOSED TO MOISTURE. DAMAGES TO THE SENSOR RECEPTACLE AND THE BATTERY COMPARTMENT WERE ALSO NOTED. FUNCTIONAL TESTING FOUND THE ALARM DID NOT SOUND AS DESIGNED WHEN IN USE WITH A SENSOR PAD. UPON OPENING THE DEVICE, THE CAUSE FOR THE FAILURE WAS A FAULTY SPEAKER, WHERE THE SPEAKER IMPEDANCE WAS OUT OF RANGE. 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 AGE OF THE DEVICE, IT IS LIKELY EXPECTED NORMAL WEAR AND TEAR CONTRIBUTED TO THE DEFECT. 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 IS NOT IN WORKING CONDITION. EVALUATION FOUND THE ALARM HAS POWER BUT DOES NOT SOUND. 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
    706457 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1