BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ON CUE

    MDR report key: 11975770 · Received June 10, 2021

    Report

    Report Number
    2020362-2021-00032
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Report Date
    June 28, 2021
    Manufacturer
    POSEY PRODUCT
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE UNITS RETURNED WERE EVALUATED BY POSEY PRODUCTS; AT WHICH TIME, THEY WERE FOUND TO BE FUNCTIONING ACCORDING TO MANUFACTURING SPECIFICATIONS. EVEN IF COSMETIC DAMAGE IS NOTED, THE EVIDENCE SUPPORTS THAT A DEVICE MALFUNCTION DID NOT OCCUR. 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 B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT IS SCHEDULED TO BE RETURNED BUT HAS NOT BEEN RECEIVED IN BY MANUFACTURER AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. AN INVESTIGATION OF SIMILAR COMPLAINTS REVEALED SEVERAL POTENTIAL CAUSES, INCLUDING FAULTY OR DAMAGED COMPONENTS. MANY OF THE PROBLEMS ARE EITHER DAMAGE TO THE NURSE CALL RECEPTACLE AND FAULTY NURSE CALL RELAY. DAMAGE CAN CAUSE THE PINS INSIDE THE NURSE CALL RECEPTACLE TO BECOME STUCK DOWN, EITHER TRIGGERING NO ALARM OR FALSE ALARM. IT CAN ALSO CAUSE THE NURSE CALL CABLE TO NOT HAVE A SECURE FIT IN THE RECEPTACLE, WHICH CAN ALLOW MOVEMENT TO AFFECT FUNCTION. OTHER CAUSES, SUCH AS CORROSION AND MOISTURE DAMAGE, ARE ALSO A POSSIBILITY. 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 (B)(4).

    Description of Event or Problem · 0

    SUPPLEMENTAL REQUIRED FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    TM CONTACTED VIA EMAIL REGARDING AN EXCHANGE FOR SITTER ON CUE 2.0 ALARMS INSTEAD OF THE 1.0 VERSION. TM REPORTED THE ALARMS TRIGGER THE NURSE CALL SYSTEM ALL AT ONCE, WHILE OTHERS DO NOT TRIGGER AT ALL. NO GTIN NUMBER PROVIDED, TROUBLESHOOTING GUIDE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877209 SITTER ON CUE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCT 8645 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1