BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONITOR, BED ALARM, AUTO RESET

    MDR report key: 18317876 · Received December 13, 2023

    Report

    Report Number
    1060680-2023-00015
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    August 15, 2023
    Report Date
    January 30, 2024
    Manufacturer
    RONDISH COMPANY LIMITED
    Product Code
    KMI
    UDI-DI
    00749756980449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON 11/22/2023 REPORTING ACCORDING TO THE NURSING STAFF, THE PATIENT WAS OOB (OUT OF BED) AND THE BED ALARM FAILED TO ALARM TIMELY. WHEN THEY HEARD THE ALARM, THE PATIENT WAS ALREADY ON THE FLOOR. THUS, THE STAFF FEEL THAT THERE WAS A DELAY IN THE ALARM. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE BED ALARM SUPPLIER SMART CAREGIVER. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (#(B)(4)) WAS RECEIVED ON 11/22/2023 REPORTING ACCORDING TO THE NURSING STAFF, THE PATIENT WAS OOB (OUT OF BED) AND THE BED ALARM FAILED TO ALARM TIMELY. WHEN THEY HEARD THE ALARM, THE PATIENT WAS ALREADY ON THE FLOOR. THUS, THE STAFF FEEL THAT THERE WAS A DELAY IN THE ALARM. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE BED ALARM SUPPLIER SMART CAREGIVER. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED BY THE SUPPLIER SMART CAREGIVER. DUE TO THE SAMPLE NOT BEING RETURNED FOR EVALUATION. DUE TO NO ROOT CAUSE BEING DETERMINED THERE WERE NO CORRECTIVE AND PREVENTIVE ACTIONS TAKEN BY SMART CAREGIVER. AN INVENTORY CHECK OF THE MONITOR, BED ALARM WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF THE M2100-SL2 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ACCORDING TO THE NURSING STAFF, THE PATIENT WAS OOB (OUT OF BED) AND THE BED ALARM FAILED TO ALARM TIMELY. WHEN THEY HEARD THE ALARM, THE PATIENT WAS ALREADY ON THE FLOOR. THUS, THE STAFF FEEL THAT THERE WAS A DELAY IN THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581258 MONITOR, BED ALARM, AUTO RESET MONITOR, BED PATIENT KMI RONDISH COMPANY LIMITED M2100-SL2 00749756980449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R