BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESENSE BSN-020

    MDR report key: 1000975 · Received February 19, 2008

    Report

    Report Number
    1650927-2008-00001
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 15, 2008
    Manufacturer
    NURSE ASSIST, INC.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING OF THE RETURNED SENSOR PAD REVEALED AN INTERMITTENT CONNECTION AT THE SENSOR PAD MODULAR CONNECTOR. FURTHER INSPECTION REVEALED THAT THE WIRES HAD BEEN PULLED BACK FROM THE CONTACT CRIMPS. IT IS BELIEVED THAT THIS WAS A RESULT OF EXCESSIVE PULLING ON THE CABLE. ALL SENSOR PADS ARE 100% TESTED FOR CONTINUITY 2 TIMES DURING THEIR MANUFACTURING PROCESS. NON FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    RESIDENT FELL WHILE BEING MONITORED BY A SENSOR PAD. PAD AND MONITOR FAILED TO SIGNAL CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESENSE BSN-020 BED EXIT SENSOR PAD KMI NURSE ASSIST, INC. BSN-020 710146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Hospitalization