BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 11924809 · Received June 2, 2021

    Report

    Report Number
    2020362-2021-00029
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Report Date
    May 10, 2021
    Manufacturer
    POSEY PRODUCT
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: VISUAL FINDINGS OBSERVED EXCESSIVE FORCE OR IMPACT ON THE FRONT SIDE OF THE RETURNED UNIT AS IT HAS DEEP SCRATCHES AND INDENTATION. SITE STICKERS ATTACHED ON LEFT SIDE GREEN OVER MOLD. ONE OF THE DUST COVERS UNDERNEATH THE BATTERY SLOT IS BROKEN. THE UNIT WAS RECEIVED WITH BATTERIES INSIDE. EVALUATION FOUND THE UNIT DID NOT SOUND WHEN THE PULL MAGNET WAS TAKEN OFF THE MAGNET PLATE DUE TO A FAULTY REED SWITCH. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING WHILE USING A SENSOR PAD. BEING THAT THE UNIT HAS BEEN IN USE FOR OVER 4 YEARS, IT IS LIKELY 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 (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. MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IS CALLING ABOUT AN ALARM THAT WILL NOT MAKE NOISE. THIS WILL OCCUR WHEN THE MAGNET HAS BEEN REMOVED FROM THE PLATE. NO GTIN NUMBER PROVIDED, TROUBLESHOOTING GUIDE SAVED. 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
    821819 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCT 8345 1742KF0577

    Patients

    Seq Age Sex Outcome Treatment
    1