BEUDAMED
    FDA Adverse Event Summary report: N

    LIFESYNCH WIRELESS PATIENT TRANSCEIVER

    MDR report key: 1746542 · Received June 16, 2010

    Report

    Report Number
    1746542
    Date Received
    June 16, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 16, 2010
    Manufacturer
    LIFESYNCH CORPORATION
    Product Code
    DRG
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DATA FROM CARDIAC MONITORING STOPPED TRANSMITTING. A "LEADS FAIL" ALARM OCCURRED. WHEN THE RN RESPONDED TO THE LOSS OF CARDIAC MONITORING DATA, SHE IMMEDIATELY CHANGED THE BATTERY AND DOES NOT RECALL WHAT THE BATTERY STATUS LIGHTS WERE. IT IS POSSIBLE THAT THE BATTERY DEPLETED AND THAT THE STAFF DID NOT HEAR THE AUDIBLE ALARM OR SEE THE LOW BATTERY ALARM. THE PATIENT WAS DISCOVERED PULSELESS AND CPR/ACLS WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNCH WIRELESS PATIENT TRANSCEIVER TRANSMITTER, PHYSIOLOGICAL DRG LIFESYNCH CORPORATION LS-101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *