BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADCALL

    MDR report key: 7859576 · Received September 10, 2018

    Report

    Report Number
    7859576
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    July 18, 2018
    Report Date
    August 22, 2018
    Manufacturer
    CURBELL MEDICAL PRODUCTS, INC
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SITTING IN A RECLINER CHAIR BEDSIDE WITH A CHAIR ALARM AND CALL BELL ON/WITH PATIENT. NURSE ROUNDED ON PATIENT WHO DECLINED ANY NEEDS AT THAT TIME. WHEN THE NURSE MADE IT OUT TO THE NURSE DESK SHE HEARD THE CHAIR ALARM. SHE IMMEDIATELY RETURNED TO THE ROOM AND FOUND THE PATIENT SLIDING OVER THE LEFT ARM OF RECLINER TO THE FLOOR. THE PATIENT WAS ATTEMPTING TO GET UP OFF THE FLOOR. THE FALL RESPONSE TEAM WAS CALLED BUT THERE WAS NO RESPONSE AS THE TIME OF DAY HAD NO STAFF TO COVER (APPROX. 0630). THE PATIENT WAS ASSISTED TO THE BED BUT WAS INSISTING ON GOING TO THE BATHROOM. THE NURSE REPORTED THAT THE PATIENT WAS ASSISTED TO THE BATHROOM AS HE HAD REFUSED TO USE THE URINAL SEVERAL TIMES DURING HER SHIFT AND HE CONTINUED TO REFUSE TO USE IT. PATIENT RETURNED FROM BATHROOM AND NURSE ATTEMPTED TO PLACE HIM IN BED BUT PATIENT REFUSED AND WAS PLACED BACK INTO THE CHAIR. CHAIR ALARM WAS PLACED ON PATIENT AGAIN AND HE WAS GIVEN CALL BELL. AT THIS TIME NURSE FOUND THAT CALL BELL WAS NOT WORKING, NURSE CLAIMS CALL BELL HAD BEEN WORKING WHEN HE WAS INITIALLY ASSISTED INTO CHAIR. ENGINEERING WAS MADE AWARE OF FAULTY CALL BELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701063 PADCALL SYSTEM, COMMUNICATION, POWERED ILQ CURBELL MEDICAL PRODUCTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA